Growth hormone axis · Evidence tier B
MK-677 (ibutamoren)
ibutamoren · ibutamoren mesylate · MK-0677 · MK0677 · MK677 · L-163,191 (Merck’s early research code)
MK-677 is an experimental pill, not a peptide, that makes the body release more growth hormone1. In older adults it added lean mass but not strength and raised blood sugar2; a hip-fracture trial stopped early over a heart failure signal3.

Quick answers
- What is it?
- A lab-made pill that mimics the hormone ghrelin, so the body releases more growth hormone and feels hungrier12. It is a small drug molecule, not a peptide1. It is grouped with peptides because it works like growth hormone peptides and is sold beside them45.
- Does it work?
- It raises growth hormone: 25 mg a day nearly doubled it in older adults after 2 weeks6. Over 1 year it added about 1 kg of lean mass, but not strength2. It did not slow Alzheimer’s disease or clearly speed hip-fracture recovery378.
- Is it safe?
- In older adults it raised blood sugar, and short-lived leg swelling and muscle pain were reported more often than on placebo12. A hip-fracture trial was stopped early after more heart failure on the drug13. FDA says long-term effects are unknown9.
What it is
MK-677, also called ibutamoren, is a lab-made drug taken by mouth. It binds to and switches on the receptor for the hormone ghrelin on growth hormone-making cells in the pituitary gland and on nerve cells in the hypothalamus, so the body releases more of its own growth hormone1. It also increases appetite12. More growth hormone in turn raises insulin-like growth factor 1 (IGF-1)16. It works through a different receptor from growth hormone-releasing hormone, whose lab-made copies include sermorelin and tesamorelin1216. It is not a peptide: FDA describes it as a non-peptide small molecule, though its structure contains serine and 2-aminoisobutyric acid, an amino acid not used to build proteins1. It is grouped with peptides because it acts like them. Its Merck developers found it worked in the same way as GHRP-6, a growth hormone-releasing peptide4. FDA places it in one drug class, growth hormone secretagogues, that includes both peptides and non-peptides, and the anti-doping list names it beside ipamorelin112. Sellers also offer it alongside injectable peptides5. Unlike those peptides, it works when swallowed: FDA cites a 1997 paper stating that a single dose is long-acting (24 hours) and active by mouth1. The form nominated for compounding, and named in trial reports, is a salt, ibutamoren mesylate1316.
Merck researchers made MK-677, first coded L-163,191, in 1995 while looking for a growth hormone booster that works by mouth14. It was then tested in healthy older adults, obese men, older women with low bone density, and people with Alzheimer’s disease or a recent hip fracture36781718. FDA’s 2024 review says development was discontinued in 1999, yet ClinicalTrials.gov lists Merck-sponsored trials in Alzheimer’s disease (October 2003 to January 2006) and after hip fracture (September 2005 to August 2007, terminated early)11920. Lumos Pharma later licensed it and renamed it LUM-201 for children with growth hormone deficiency121. A placebo-controlled final-stage (Phase 3) trial in such children lists a start date of 20 May 2026, and a trial pairing it with oral semaglutide in older adults with obesity was listed on 10 August 2026 as not yet recruiting, with a planned start of 15 February 20272223.
Benefits: what the research shows
Most human trials gave 25 mg by mouth once a day, and most enrolled older adults. In 32 healthy adults aged 64 to 81, 25 mg a day nearly doubled average 24-hour growth hormone levels after 2 weeks and raised IGF-1 into the normal range for young adults by 4 weeks, while fasting blood sugar rose from 5.4 to 6.8 mmol/L6. The longest trial randomized 71 healthy adults aged 60 to 81 to 25 mg a day or placebo, and 65 completed the first year. Fat-free mass (lean mass, which includes muscle and body water) rose by 1.1 kg on the drug and fell by 0.5 kg on placebo, and weight rose by 2.7 kg vs 0.8 kg. Limb fat rose more on the drug, but deep belly fat and total fat did not differ. Strength and physical function did not change, although the trial was too small to test function well2. Fasting blood sugar rose by 0.3 mmol/L (5 mg/dL), insulin sensitivity fell, the stress hormone cortisol rose and LDL cholesterol fell slightly2. In 24 obese men, 8 weeks of 25 mg raised IGF-1 by about 40% and increased fat-free mass, but total fat and deep belly fat did not change, and a glucose tolerance test worsened at 2 and 8 weeks17. In 8 healthy young adults on a low-calorie diet, 7 days of 25 mg turned the diet’s protein loss into a small gain (nitrogen balance +0.31 g/day vs -1.48 g/day on placebo)25. In a small sleep study, 25 mg at bedtime for 7 days increased deep (stage IV) sleep by about 50% and REM sleep by more than 20% in 8 young adults compared with placebo; in 6 older adults, REM sleep rose by nearly 50% compared with their own baseline26. Trials aimed at diseases were mostly negative. In 563 people with mild to moderate Alzheimer’s disease, a year of 25 mg raised IGF-1 by about 73% but did not slow the disease on any measure7. After hip fracture, a 6-month trial in 161 older adults found no significant gain in function8. A second, 24-week trial in 123 patients found a small gain in gait speed but none in stair-climbing power or most other measures, and it was stopped early over a heart failure signal: FDA’s review counts congestive heart failure in 4 patients (6.5%) on the drug vs 1 (1.7%) on placebo13. In 292 older women with low hip bone density, the drug raised markers of bone turnover; combined with the osteoporosis drug alendronate, it raised bone density at the femoral neck, part of the hip, by 4.2% vs 2.5% with alendronate alone, but not at the spine, total hip or whole body18. In 22 people on hemodialysis, each given 25 mg a day for 1 month and placebo for another month, IGF-1 rose 65% more on the drug than on placebo, with no serious side effects attributed to it27. In an open-label pilot study in adults with fatty liver disease, 6 months of 25 mg did not lower liver fat; only 7 of 12 finished, and the results were posted on 6 January 202628. In 9 young men with severe growth hormone deficiency, 4 days of 10 or 50 mg raised IGF-1 by 52% and 79%29, and in 18 children with growth hormone deficiency, 7 to 8 days of treatment raised IGF-1 in some of them16. In a randomized trial whose results were posted on 17 June 2026, 82 children with growth hormone deficiency who had responded to a test dose took LUM-201 by mouth or daily growth hormone injections, and growth was compared after 6 months. In the registry’s per-protocol analysis, their growth rates, expressed per year, were 6.8 to 8.2 cm on LUM-201 vs 10.6 cm on injections; 43 of the 62 children on LUM-201 did not complete the randomized phase, 39 of them after failing the growth-rate criteria or moving early to an extension study30. A placebo-controlled trial in children is recruiting, with completion estimated for January 202822. FDA’s 2024 review found ‘insufficient information’ to support its use for growth hormone deficiency, osteoporosis, hip fracture, sarcopenia (age-related muscle loss), obesity or Alzheimer’s disease1. We found no controlled trial in young, healthy people who lift weights5152.
Key human studies
| Study | Design | People | Dose and route | Result |
|---|---|---|---|---|
| Nass et al., Ann Intern Med 20082PubMed · DOI | Randomized, double-blind, placebo-controlled trial over 2 years (modified crossover in year 2) at a university hospital research center, treating healthy adults aged 60-81 from 1998 to 2003; 71 randomized, 65 completed the first year; Merck supplied the tablets | 65 | 25 mg by mouth once daily vs placebo | At 12 months, fat-free mass rose 1.1 kg vs a 0.5 kg fall on placebo (P<0.001); strength and function did not change, but the trial was underpowered for them. Weight rose 2.7 vs 0.8 kg and limb fat rose; deep belly fat and total fat did not differ. Fasting glucose rose 0.3 mmol/L (P=0.015) and insulin sensitivity fell; cortisol rose. Appetite rose at first, and mild leg swelling and muscle pain were short-lived2. |
| Adunsky et al., Arch Gerontol Geriatr 20113PubMed · DOI | Multicenter, randomized, double-blind, placebo-controlled Phase IIb trial in older adults recovering from hip fracture; terminated early | 123 | 25 mg by mouth once daily (n=62) vs placebo (n=61) for 24 weeks | Stair-climbing power +12.5 W vs placebo (P=0.292); gait speed better by a 0.7-score difference (P=0.011); no improvement in several other performance measures. IGF-1 +51.4 ng/mL. Stopped early over a heart failure signal: FDA’s review counts congestive heart failure in 4 patients (6.5%) on the drug vs 1 (1.7%) on placebo, and serious adverse events in 24% vs 13%13. |
| Sevigny et al., Neurology 20087PubMed · DOI | Multicenter, randomized, double-blind, placebo-controlled trial in mild to moderate Alzheimer’s disease; 563 randomized, 416 completed | 563 | 25 mg by mouth once daily vs placebo for 12 months | IGF-1 rose 60.1% at 6 weeks and 72.9% at 12 months, but no measure of disease progression differed from placebo (CIBIC-plus, ADAS-Cog, ADCS-ADL, CDR-sob); the authors judged it ineffective. FDA’s review lists drug-related adverse events in 35.5% vs 23.9% and raised blood glucose in 15.4% vs 4.6%17. |
| Murphy et al., J Clin Endocrinol Metab 200118PubMed · DOI | Multicenter, randomized, double-blind, placebo-controlled, 18-month trial in women aged 64-85 with low femoral neck bone density, assigned 3:3:1:1 to MK-677 plus alendronate, alendronate, MK-677 or placebo for 12 months; all took 500 mg calcium a day | 292 | 25 mg by mouth once daily, with or without alendronate 10 mg daily; the MK-677-alone and placebo groups switched to the combination for months 12-18 | MK-677 raised IGF-1 (39% and 45%), osteocalcin (22%) and urinary NTx (41%), markers of bone formation and breakdown. With alendronate, femoral neck bone density rose 4.2% vs 2.5% with alendronate alone (P<0.05), but not at the spine, total hip or whole body. Side effects linked to growth hormone were noted18. |
| Copinschi et al., Neuroendocrinology 199726PubMed · DOI | Double-blind, placebo-controlled, three-period crossover in 8 young adults aged 18-30, plus an uncontrolled study against baseline in 6 adults aged 65-71 | 14 | Young adults: 5 mg, 25 mg or placebo by mouth at bedtime for 7 days each. Older adults: 2 mg, then 25 mg, at bedtime for 14 days each | Young adults on 25 mg: stage IV (deep) sleep up about 50% and REM sleep up more than 20% vs placebo; deviations from normal sleep fell from 42% to 8%. Older adults: REM sleep up nearly 50% vs baseline, with shorter REM latency26. |
| Lumos Pharma, NCT04614337 (results posted 2026)30NCT04614337 | Randomized, open-label, active-controlled Phase 2 trial, planned for 24 months, in children aged 3-12 with growth hormone deficiency; 104 received a qualifying test dose, 22 left for lack of response, and 82 were randomized | 82 | LUM-201 0.8, 1.6 or 3.2 mg/kg by mouth once daily vs growth hormone (Norditropin) 34 µg/kg injected under the skin once daily; main results at 6 months | In the registry’s per-protocol analysis (all 62 children on LUM-201 and 18 of 20 on growth hormone), growth over 6 months, expressed per year, was 6.76, 8.21 and 7.73 cm/year on the three LUM-201 doses vs 10.57 cm/year on growth hormone. A positive growth response (at least 6.85 cm/year) was seen in 44.4%, 72.7% and 72.7% vs 100%. Of the 62 children on LUM-201, 43 did not complete the randomized phase, 39 of them after failing the growth-rate criteria or moving early to an extension study; the growth hormone group ended at 12 months. Serious adverse events, counted over up to 2 years: 1 of 18, 1 of 22 and 0 of 22 vs 1 of 2030. |
Doses studied
Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.
In human studies
Most adult trials used 25 mg by mouth once a day: for up to 2 years in healthy older adults2, 12 months in Alzheimer’s disease7, 24 weeks after hip fracture3, up to 18 months in older women with low bone density18, 8 weeks in obese men17 and 6 months in a fatty-liver pilot study28. Other doses: 2, 10 or 25 mg a day for up to 4 weeks in older adults6; 5 or 25 mg at bedtime for 7 days in young adults26; 10 or 50 mg a day for 4 days in men with growth hormone deficiency29. FDA’s review summarizes the published range as 2 to 50 mg a day, or 0.2 to 0.8 mg/kg a day, for up to 2 years1. In the 2-year trial, the dose was lowered to 10 mg in 4 people because of high blood sugar or joint pain2. Children with growth hormone deficiency received 0.2 or 0.8 mg/kg a day for 7 to 8 days16 and, as LUM-201, 0.8, 1.6 or 3.2 mg/kg a day for 6 months30; the placebo-controlled trial that started in 2026 uses 1.6 mg/kg a day22. We found no human trial that tested injections5254.
In animal studies
Dogs: single oral doses as low as 0.125 mg/kg raised growth hormone, and 1 mg/kg did not significantly change aldosterone, luteinizing hormone, thyroxine or prolactin, with only a modest rise in cortisol4. Rats: after 6 weeks of 4 mg/kg a day by mouth, growth hormone levels were similar to those in untreated rats1. FDA’s review concludes from animal studies that the growth hormone response is likely to be lost with continuous oral dosing, that the drug can cause low blood pressure in rats, and that it may have reinforcing properties that could contribute to addiction1.
What users report Anecdotal · not validated · not a recommendation
A dosing-guide website updated 25 August 2026 lists 10 to 25 mg by mouth once a day42.
- Half-life
- No human value found; a single dose acts for about 24 hours1FDA’s 2024 review found no human half-life data. It cites one 1996 trial for the drug’s ‘high oral bioavailability and its long duration of action’ and a 1997 paper stating that a single dose is long-acting (24 hours); in dogs, more than 60% of an oral dose reaches the blood1. A dosing website’s figure of 4 to 6 hours cites no study42.
- Routes
- By mouth as tablets, capsules or liquid (all human trials)
- Injection (a 64 mg/mL product was seen for sale by FDA; no human data found)
Legal status
- United States
- Not approved for any use. FDA’s 2024 review found no FDA-approved product and no USP monograph, and ibutamoren is not part of any approved drug1. In a warning letter of 19 December 2025, FDA said ibutamoren is excluded from the legal definition of a dietary supplement, because it was authorized for study as a new drug, substantial clinical studies of it were made public, and it was not sold as a supplement or food before that11. On 23 September 2025 FDA advised consumers not to buy or use a growth supplement sold for children aged five and older, after its lab found ibutamoren that was not on the label9. In a warning letter of 12 December 2025 to an online seller of ‘MK-677 Ibutamoren’ and SARMs, FDA said that ‘for research use only’ statements did not change the fact that the products were intended as drugs for people, making them unapproved new drugs34. It is not a federally controlled substance: the DEA schedules in 21 CFR Part 1308 (as of 25 September 2026) do not name it35.
- US pharmacies
- Section 503A sets the rules for ordinary pharmacies that compound medicines for individual patients. Ibutamoren mesylate has been in Category 2 of FDA’s list of bulk substances nominated for 503A compounding since 29 September 2023, and it was still there in the list updated 14 May 20261031. Category 2 means FDA has identified ‘significant safety risks’ pending further evaluation, and FDA says it would consider acting against a pharmacy that compounds with such a substance32. A 503A pharmacy may compound from bulk powder only if the ingredient has a USP monograph, is part of an FDA-approved drug or is on the 503A bulks list; ibutamoren meets none of these, so US pharmacies may not make it11032. FDA’s stated reason is ‘the potential for congestive heart failure in certain patients’, citing the hip-fracture trial that ‘was terminated early due to a potential safety signal of congestive heart failure’31. It has also been in Category 2 for outsourcing facilities under section 503B since 29 December 202231. The nominations FDA reviewed proposed 10 and 25 mg oral products for growth hormone deficiency; one nominator later added hip fracture, sarcopenia, osteoporosis, Alzheimer’s disease, obesity and fibromyalgia1. On 29 October 2024 FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted 13 to 1 against adding it to the 503A bulks list: several members said the evidence did not support its efficacy and safety, several raised concerns about fluid retention, congestive heart failure and high blood sugar, and the one member in favor pointed to its extensive use and the data in children36. On 15 April 2026, HHS Secretary Robert F. Kennedy Jr. posted that FDA would remove 12 peptides from Category 2 after their nominators withdrew them, and his list included ibutamoren mesylate37. FDA’s own pages, checked on 5 October 2026, still list it in Category 2 and not among the withdrawn substances1031. It was not on the agenda of the July 2026 committee meeting, nor among the five substances FDA lists for the committee’s next meeting, to be held before the end of February 20273850. Even leaving Category 2 would not by itself let pharmacies make it, because FDA’s interim policy shields only Category 1 substances32.
- Other countries
- Australia: ibutamoren is a Schedule 4 (prescription only) poison and is listed in Appendix D, clause 5, of the Poisons Standard in force from 1 October 2026, which covers poisons that must not be possessed without authority, such as a legal prescription; the index cross-references the names MK-677 and Nutrobal13. Canada: Health Canada says ibutamoren (MK-677) is not authorized for any use in Canada and that selling unauthorized health products is illegal. Its advisories list ibutamoren (MK-677) products seized from supplement stores in Alberta (listed in 2023), from online sellers in Quebec (listed in 2024 and 2025), from a Quebec distributor (listed on 9 July 2025) and from two stores in Maple Ridge, British Columbia (advisory of 24 December 2025)539. EU: FDA’s review found no product authorized by the European Medicines Agency; the European Commission granted ibutamoren mesylate orphan designation for growth hormone deficiency in June 20171. FDA’s review, citing a university report, also found no approved product in Canada, the UK, Ireland, Australia, New Zealand and several other countries1. UK legal status beyond that: not verified.
- Sport
- Prohibited at all times, in and out of competition. The 2026 List names ‘ibutamoren (MK-677)’ among the growth hormone secretagogues under S2.2.4, a non-Specified class, alongside ipamorelin and macimorelin12. The 2027 List, in force from 1 January 2027, keeps the same wording33. In a case posted on 20 February 2026, the US Anti-Doping Agency gave a 46-year-old masters weightlifter a three-year ban after a urine sample collected at a competition on 5 December 2025 tested positive for ipamorelin and ibutamoren40. A 2026 lab study found ibutamoren in a volunteer’s hair 4 weeks after a single 10 mg dose41.
Quality and the gray market
What testing finds
Finnrick, a service that publishes lab results for peptide samples, listed 11,999 tests of 34 products from 466 vendors as of 25 September 2026, and none were of MK-67714. In a 2017 US study of 44 products sold online as SARMs, 17 (39%) contained a different unapproved drug, such as ibutamoren, 11 (25%) contained substances not on the label, and only 18 (41%) held the labeled amount43. Over 5 years, 14 laboratories in 13 countries belonging to the General European Official Medicines Control Laboratories Network (GEON) reported on 324 suspected illegal products bought as sport performance enhancers; ibutamoren was among the top five of 18 molecules found, and from the limited dose data reported, most samples appeared to contain active doses and some were overdosed15. FDA’s lab found ibutamoren, not listed on the label, in a children’s growth supplement in 20259. In a 2024 case report, the 3 gym supplements a man had used contained MK-677, RAD-140 and cardarine between them, and all 3 also held testosterone, estradiol and growth hormone that were not disclosed44. FDA’s 2024 review found that the nominators’ certificates of analysis reported 99.36% and 99.60% purity but included no tests for chiral purity, related impurities or residual solvents. It flagged possible methanesulfonate impurities, such as the mutagen ethyl methanesulfonate, from the final synthesis step1.
How it is sold
FDA found websites selling ibutamoren as 10 to 25 mg capsules, 20 mg tablets, a 64 mg/mL injection, 1 g of powder and liquids of 17 to 67 mg/mL; some said their products were for research purposes only1. It is marketed online to reverse aging and, wrongly, as a SARM for bodybuilding and weightlifting. Claimed benefits include more muscle, less body fat, stronger bones, better sleep, skin and thinking, faster healing and higher libido1. An expert interviewed for a University of Maryland report cited by FDA described growth hormone secretagogues as ‘lifestyle medications’ for skin, hair or body, often used with testosterone, and one outsourcing facility reported compounding 25 mg capsules in 2019 and 20201. A seller that received an FDA warning letter on 12 December 2025 called it ‘MK677, also recognized as Ibutamoren, Oratrope, or Nutrobal’ and claimed it reduces body fat and increases muscle mass and bone density34. The trials do not support all of these claims: lean mass rose but strength did not, body fat did not fall, Alzheimer’s disease did not slow, and bone density rose at only one hip site, and only when combined with an osteoporosis drug271718. In Canada, MK-677 products have been seized from supplement stores and online sellers, sometimes beside injectable peptides, SARMs and steroids539. On 30 September 2026 one online seller’s homepage listed MK-677 among its four ‘Most Popular’ products45. A dosing website updated 25 August 2026 says users gain 1 to 2 kg of lean mass over 8 to 12 weeks while losing fat, that strength in major lifts rises 5% to 15%, and that improved insulin sensitivity is documented, without citing a trial42. In the first year of the 2-year trial in older adults, insulin sensitivity fell and strength did not change2.
Side effects and risks
- Heart failure and blood pressure: a hip-fracture trial was stopped early after congestive heart failure in 4 patients (6.5%) on the drug vs 1 (1.7%) on placebo, and systolic blood pressure rose by 11.9 to 16.4 mmHg on the drug vs -2.3 to +2.3 mmHg on placebo13. Heart failure risk is the reason FDA gives for listing it as a significant safety risk in compounding31.
- Blood sugar: it raised fasting glucose and lowered insulin sensitivity in healthy older adults2. In the Alzheimer’s trial, FDA’s review counts raised blood glucose in 15.4% on the drug vs 4.6% on placebo1. One hip-fracture trial excluded people with diabetes or heart failure, so its results say nothing about them8.
- Fluid retention, pain and hunger: in the first year of the 2-year trial in older adults, FDA’s review counts swelling in 19 of 43 people on the drug vs 6 of 22 on placebo, muscle pain in 14 vs 2 and increased appetite in 29 vs 81. Side effects that led people to stop in trials included high blood sugar, high prolactin, raised liver enzymes and high blood pressure1.
- Hormones and cancer: cortisol rose in older adults, and prolactin rose by 23%26. FDA notes that older people with high IGF-1 levels have been observed to be at higher risk of disease or death, and that higher IGF-1 levels appeared to be associated with cancer risk at all ages1.
- Liver: a 2025 case report describes raised liver enzymes after 2 months of MK-677 that returned to normal after stopping46. As of 30 July 2026, FAERS held 5 liver injury reports naming MK-677 (3 appear to describe the same 25-year-old man), and all 5 also list SARMs47.
- Animal and theoretical concerns: FDA’s review says the drug may have reinforcing properties that could contribute to addiction and that it caused low blood pressure in rats; in animal studies, another substance acting on the same receptor harmed development when given during pregnancy. FDA also notes that macimorelin, an approved drug of the same class, carries a risk of QT prolongation (a heart rhythm effect), and that there are too few data to rule out similar concerns1.
- Product risks: products sold as SARMs often contain unlisted drugs, including ibutamoren43, and supplements containing MK-677 have also held undisclosed hormones44.
- Anti-doping and legal: banned in sport at all times; in February 2026 the US Anti-Doping Agency announced a three-year ban, counted from December 2025, for a masters weightlifter1240. Having it without a prescription is illegal in Australia13.
Documented harms
- Sep 2011A 24-week hip-fracture trial was stopped early over a safety signal of congestive heart failure. FDA’s review counts heart failure in 4 patients (6.5%) on the drug vs 1 (1.7%) on placebo, and serious adverse events in 24% vs 13%, including one death on the drug from sepsis and pneumonia that was judged unrelated13.
- 30 Jul 2026FAERS, FDA’s adverse event database, held 14 reports naming ibutamoren or MK-677 as of its 30 July 2026 update. Only 3 name it alone: vomiting and stomach pain; malaise and numbness; and, in a 22-year-old man, abnormal behavior, vomiting blood, suicidal thoughts and withdrawal symptoms. The rest also list other products, often SARMs or testosterone, and include liver injury, blood clots and strokes. FAERS reports cannot show that a product caused an event47.
- 23 Sep 2025FDA advised consumers not to buy or use a growth supplement sold for children aged five and older after its lab found ibutamoren that was not on the label. FDA listed possible effects including increased appetite, water retention, fatigue, muscle pain, changes in blood sugar control and possibly heart failure9. A warning letter to the company followed on 19 December 202511.
- Dec 2022A 25-year-old man took LGD-4033 (10 mg) and MK-677 (15 mg) daily for 5 weeks. His body mass rose 6.0% and his fat mass 15.4%; total testosterone fell 62.3%, HDL cholesterol fell 36.4%, LDL cholesterol rose 40% and the liver enzyme ALT rose 205%. Most values recovered after he stopped, but fat mass, bone area, total cholesterol and LDL did not48.
- Aug 2024A 40-year-old man developed breast enlargement (gynecomastia) and low sex hormones after 6 months of gym supplements containing RAD-140, MK-677 and cardarine; lab tests also found undisclosed testosterone, estradiol and growth hormone in them. Both problems resolved after he stopped44.
- 17 Jul 2025A healthy man in his early 30s developed raised liver enzymes after 2 months of MK-677; his liver tests returned to normal after he stopped46.
- Mar 2026A 54-year-old man who had recently used MK-677 and RAD-140 for bodybuilding had a spontaneous rupture of the spleen and needed embolization and then removal of the spleen. The authors called a role for the compounds speculative and found signs of a possible vascular malformation49.
Questions people ask
Is MK-677 a peptide?
No. FDA describes ibutamoren as a non-peptide small molecule that switches on the ghrelin receptor1. It is discussed with peptides because it boosts growth hormone in the same way as growth hormone-releasing peptides such as GHRP-6, and the anti-doping list puts it in the same class as ipamorelin412.
Is MK-677 a SARM?
No. FDA says ibutamoren is a growth hormone secretagogue, not a SARM, although several websites wrongly classify it as one1. It has turned up in products sold as SARMs43.
Is MK-677 legal in the US?
It is not approved, US pharmacies may not compound it, and FDA says it cannot be sold as a dietary supplement11011. It is not a federally controlled substance35. FDA has sent warning letters to sellers, including one that labeled its products for research use only34.
Does MK-677 build muscle?
In older adults, a year of 25 mg a day added about 1 kg of fat-free mass but did not improve strength or function2. In obese men it raised fat-free mass over 8 weeks17. We found no controlled trial that tested it in young people who lift weights5152.
Does MK-677 raise blood sugar?
Yes. In healthy older adults it raised fasting blood sugar and lowered insulin sensitivity over a year2, and in obese men it worsened glucose tolerance at 2 and 8 weeks17. High blood sugar was one of the concerns behind FDA advisers’ 2024 vote against allowing it in pharmacy compounding36.
What is still unknown
- We found no controlled trial that tested MK-677 in young, healthy people who lift weights, the group it is mostly marketed to.
- FDA’s 2024 review found no human half-life data; the only human data it cites are statements that one dose acts for about 24 hours.
- Safety beyond 2 years, and in people with diabetes or heart disease, is unknown.
- HHS Secretary Kennedy’s 15 April 2026 list of 12 peptides leaving Category 2 named ibutamoren, but FDA’s pages still list it in Category 2; whether FDA will act on it is unknown.
- Results of the placebo-controlled LUM-201 trial in children (NCT06948214) are not expected before 2028.
- UK legal status was not verified, and EU status is known only through FDA’s review.
- Whether the registered Merck trials NCT00074529 and NCT00128115 are the published Alzheimer’s and hip-fracture trials was not confirmed; their enrollment counts (512 and 83) differ from the papers (563 and 123).
- The content and purity of gray-market MK-677 products are unknown; Finnrick, the public lab-testing service we checked, had no MK-677 results as of 25 September 2026.
Sources
- 1FDA Briefing Document, Pharmacy Compounding Advisory Committee meeting of October 29, 2024: ibutamoren mesylate (FDA evaluation dated 3 July 2024) U.S. Food and Drug Administration, 3 Jul 2024. fda.gov
- 2Effects of an oral ghrelin mimetic on body composition and clinical outcomes in healthy older adults: a randomized trial Annals of Internal Medicine, 4 Nov 2008. pubmed.ncbi.nlm.nih.gov
- 3MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study Archives of Gerontology and Geriatrics, Sep 2011. pubmed.ncbi.nlm.nih.gov
- 4Design and biological activities of L-163,191 (MK-0677): a potent, orally active growth hormone secretagogue Proceedings of the National Academy of Sciences, 18 Jul 1995. pubmed.ncbi.nlm.nih.gov
- 5Unauthorized health products seized from two stores in Maple Ridge, BC may pose serious health risks (RA-81404) Health Canada, 24 Dec 2025. recalls-rappels.canada.ca
- 6Stimulation of the growth hormone (GH)-insulin-like growth factor I axis by daily oral administration of a GH secretogogue (MK-677) in healthy elderly subjects The Journal of Clinical Endocrinology & Metabolism, Dec 1996. pubmed.ncbi.nlm.nih.gov
- 7Growth hormone secretagogue MK-677: no clinical effect on AD progression in a randomized trial Neurology, 18 Nov 2008. pubmed.ncbi.nlm.nih.gov
- 8The effects of MK-0677, an oral growth hormone secretagogue, in patients with hip fracture Journal of the American Geriatrics Society, Apr 2004. pubmed.ncbi.nlm.nih.gov
- 9Agebox iKids Growth Day Formula may be harmful due to hidden ingredient U.S. Food and Drug Administration, 23 Sep 2025. fda.gov
- 10Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
- 11Warning letter to Agebox Inc. (MARCS-CMS 718252) U.S. Food and Drug Administration, 19 Dec 2025. fda.gov
- 12World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
- 13Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
- 14Finnrick public data summary (llms-full.txt, generated 25 September 2026) Finnrick, 25 Sep 2026. finnrick.com
- 15SARMs, Metabolic Modulators and Growth Hormone Secretagogues in Suspected Illegal Medicines, Bought as Sport Performance Enhancers: A Retro- and Prospective Study Within the GEON Drug Testing and Analysis, Oct 2025. pubmed.ncbi.nlm.nih.gov
- 16Effects of oral administration of ibutamoren mesylate, a nonpeptide growth hormone secretagogue, on the growth hormone-insulin-like growth factor I axis in growth hormone-deficient children Clinical Pharmacology & Therapeutics, Jul 2001. pubmed.ncbi.nlm.nih.gov
- 17Two-month treatment of obese subjects with the oral growth hormone (GH) secretagogue MK-677 increases GH secretion, fat-free mass, and energy expenditure The Journal of Clinical Endocrinology & Metabolism, Feb 1998. pubmed.ncbi.nlm.nih.gov
- 18Effect of alendronate and MK-677 (a growth hormone secretagogue), individually and in combination, on markers of bone turnover and bone mineral density in postmenopausal osteoporotic women The Journal of Clinical Endocrinology & Metabolism, Mar 2001. pubmed.ncbi.nlm.nih.gov
- 19Study of MK0677 for the Treatment of Alzheimer’s Disease (0677-030)(COMPLETED) (NCT00074529) ClinicalTrials.gov, 24 Jul 2015. clinicaltrials.gov
- 20Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032) (NCT00128115) ClinicalTrials.gov, 20 Jan 2016. clinicaltrials.gov
- 21A GH Secretagogue Receptor Agonist (LUM-201) Elicits Greater GH Responses than Standard GH Secretagogues in Subjects of a Pediatric GH Deficiency Trial Hormone Research in Paediatrics, 2022. pubmed.ncbi.nlm.nih.gov
- 22Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency (NCT06948214) ClinicalTrials.gov, 4 Sep 2026. clinicaltrials.gov
- 23Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults (NCT07754045) ClinicalTrials.gov, 10 Aug 2026. clinicaltrials.gov
- 24Ibutamoren, PubChem compound summary (CID 178024) PubChem, U.S. National Library of Medicine, accessed 5 Oct 2026. pubchem.ncbi.nlm.nih.gov
- 25MK-677, an orally active growth hormone secretagogue, reverses diet-induced catabolism The Journal of Clinical Endocrinology & Metabolism, Feb 1998. pubmed.ncbi.nlm.nih.gov
- 26Prolonged oral treatment with MK-677, a novel growth hormone secretagogue, improves sleep quality in man Neuroendocrinology, Oct 1997. pubmed.ncbi.nlm.nih.gov
- 27Oral ghrelin receptor agonist MK-0677 increases serum insulin-like growth factor 1 in hemodialysis patients: a randomized blinded study Nephrology Dialysis Transplantation, 1 Mar 2018. pubmed.ncbi.nlm.nih.gov
- 28The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease (NCT05364684) ClinicalTrials.gov, 6 Jan 2026. clinicaltrials.gov
- 29Oral administration of growth hormone (GH) releasing peptide-mimetic MK-677 stimulates the GH/insulin-like growth factor-I axis in selected GH-deficient adults The Journal of Clinical Endocrinology & Metabolism, Oct 1997. pubmed.ncbi.nlm.nih.gov
- 30Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial) (NCT04614337) ClinicalTrials.gov, 17 Jun 2026. clinicaltrials.gov
- 31Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration, 22 Apr 2026. fda.gov
- 32Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act U.S. Food and Drug Administration, 14 May 2026. fda.gov
- 33World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
- 34Warning letter to Dynamic Health Group dba SARMS America (MARCS-CMS 719257) U.S. Food and Drug Administration, 12 Dec 2025. fda.gov
- 3521 CFR Part 1308, Schedules of Controlled Substances (eCFR, as of 25 September 2026) Electronic Code of Federal Regulations (eCFR), 25 Sep 2026. ecfr.gov
- 36Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 U.S. Food and Drug Administration, 15 Jan 2025. fda.gov
- 37X post by HHS Secretary Robert F. Kennedy Jr. (@SecKennedy) on peptides removed from Category 2 X (formerly Twitter), 15 Apr 2026. x.com
- 38July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee U.S. Food and Drug Administration, 6 Aug 2026. fda.gov
- 39Unauthorized workout supplements may pose serious health risks (RA-73367) Health Canada, 9 Jul 2025. recalls-rappels.canada.ca
- 40Weightlifting Athlete Accepts Sanction for Anti-Doping Rule Violations U.S. Anti-Doping Agency, 20 Feb 2026. usada.org
- 41Knowing the minimal detectable dose can facilitate the interpretation of a hair test result: II. Case example with ibutamoren (MK-677), a growth hormone secretagogue Clinica Chimica Acta, 1 Jan 2026. pubmed.ncbi.nlm.nih.gov
- 42MK-677 (Ibutamoren) Dosage, Safety & Stacks Peptide Initiative, 25 Aug 2026. peptideinitiative.com
- 43Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet JAMA, 28 Nov 2017. pubmed.ncbi.nlm.nih.gov
- 44Reversible Gynecomastia and Hypogonadism Due to Usage of Commercial Performance-Enhancing Supplement Use JCEM Case Reports, Aug 2024. pubmed.ncbi.nlm.nih.gov
- 45SwissChems homepage (‘Most Popular’ list) SwissChems (vendor), accessed 30 Sep 2026. swisschems.is (seller page, deliberately not linked)
- 46Hepatotoxicity induced by MK-677 BMJ Case Reports, 17 Jul 2025. pubmed.ncbi.nlm.nih.gov
- 47FDA Adverse Event Reporting System (FAERS) reports naming ibutamoren or MK-677, retrieved via the openFDA drug/event API U.S. Food and Drug Administration (openFDA), 30 Jul 2026. api.fda.gov · data query
- 48LGD-4033 and MK-677 use impacts body composition, circulating biomarkers, and skeletal muscle androgenic hormone and receptor content: A case report Experimental Physiology, Dec 2022. pubmed.ncbi.nlm.nih.gov
- 49Spontaneous Splenic Rupture in a Patient With Recent Use of Performance-Enhancing Compounds: A Case Report and Literature Review Cureus, Mar 2026. pubmed.ncbi.nlm.nih.gov
- 50Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027) U.S. Food and Drug Administration, 15 Apr 2026. fda.gov
- 51PubMed search: (ibutamoren OR “MK-677” OR “MK-0677” OR MK677 OR “LUM-201”) AND (“resistance training” OR “resistance exercise” OR “strength training” OR weightlifting OR “weight lifting” OR bodybuilding OR bodybuilders OR athletes) (13 results; none a trial in people who lift weights) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
- 52ClinicalTrials.gov search: ibutamoren OR MK-677 OR MK-0677 OR MK0677 OR LUM-201 (14 studies; none in young, healthy people who lift weights, none of an injected form and none of sleep) ClinicalTrials.gov, accessed 8 Oct 2026. clinicaltrials.gov
- 53PubMed search: (ibutamoren OR “MK-677” OR “MK-0677” OR MK677 OR “LUM-201”) AND sleep (5 results; the only sleep study is the 1997 one cited here) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
- 54PubMed search: (ibutamoren OR “MK-677” OR “MK-0677” OR MK677 OR “LUM-201”) AND (intravenous OR intravenously OR injection OR injections OR injected OR subcutaneous OR subcutaneously) (22 results; none a human trial of injected MK-677) National Library of Medicine (PubMed), accessed 8 Oct 2026. pubmed.ncbi.nlm.nih.gov
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