PeptideTrace
Research CompoundNon-Peptide GH Secretagogue (Oral, Unregulated)

MK-677 (Ibutamoren)

Ibutamoren, Nutrobal

C

Evidence Grade C — Moderate human evidence. 37 published studies, 28 human. 8 registered clinical trials.

8 trials37 studiesUSEUCA

Overview

MK-677 (ibutamoren) is an orally active small molecule — not a peptide — that stimulates growth hormone release by activating the ghrelin receptor. Developed by Merck, it was never approved after clinical trials showed that the growth hormone and IGF-1 increases it produced did not translate into meaningful functional improvements. It is widely available through unregulated sources.

Research Activity

37studies
Human 28
Animal 6
In-vitro 5
Reviews 3

37 published studies: 28 human, 6 animal, 5 in-vitro, 3 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

MK-677 has no marketing authorisation from any regulatory agency. Multiple clinical trials were conducted by Merck: a 2-year study in elderly subjects showed increased IGF-1 and modest body composition changes but no functional improvement. A Phase II trial in hip fracture recovery did not meet its primary endpoints. Clinical development was discontinued.

MK-677 is not a peptide but a small-molecule peptidomimetic. Despite generating pharmacological effects on growth hormone and IGF-1 levels, these effects did not translate into clinically meaningful outcomes in the trials conducted. Products available through unregulated channels lack pharmaceutical quality assurance.

Mechanism of Action

Research suggests MK-677 activates the ghrelin receptor orally, producing sustained growth hormone elevation and IGF-1 increases over 24 hours. It also stimulates appetite (consistent with ghrelin receptor activation). Unlike injectable growth hormone secretagogue peptides, its oral bioavailability allows sustained daily dosing without injection. These pharmacological observations are from clinical studies that did not demonstrate functional clinical benefit.

Research Summary

Research suggests a two-year study in elderly subjects showed increased IGF-1 levels and modest body composition changes but no functional improvement — the growth hormone elevation did not make people stronger or more mobile. A Phase II hip fracture recovery trial also failed to meet its primary endpoints. Clinical development was discontinued. Side effects include appetite and weight gain, increased fasting glucose (HbA1c rose from 5.5% to 5.8% over two years), and oedema. The unknown long-term cancer risk of sustained IGF-1 elevation is a theoretical concern. It is prohibited by WADA. Products from unregulated channels lack pharmaceutical quality assurance.

Clinical Trials

NCT06948214Phase IIIRecruiting

Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency

Lumos PharmaEndpoint: AHV after 12 months on LUM-201 compared to placeboCompletion: 2028-01-01
NCT05364684Phase IICompleted

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Massachusetts General HospitalEndpoint: Intrahepatic Lipid Content (IHL, Percent Liver Fat)Completion: 2024-12-23
NCT01343641Phase IIWithdrawn

Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects

University of VirginiaEndpoint: Lean body weight.Completion: 2010-04-01
NCT00395291N/ACompleted

Growth Hormone Secretagogue MK-0677 Effect on IGF-1 Levels in ESRD Patients

University of VirginiaEndpoint: Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.Completion: 2010-05-01
NCT00128115Phase IITerminated

Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)

Merck Sharp & Dohme LLCEndpoint: Proprietary Information - Exploratory (Non-Confirmatory) TrialCompletion: 2007-08-01
View all 8 trials on ClinicalTrials.gov →

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

Related Compounds

Somatropin

Approved
Recombinant Human Growth Hormone

Somatropin has been available since the mid-1980s and is one of the most established peptide therapies. It is sold under numerous brand names including Genotropin, Humatrope, Norditropin, and Omnitrope (the first biosimilar approved in the US, 2006). Approved indications include childhood and adult growth hormone deficiency, Turner syndrome, children born small for gestational age, Prader-Willi syndrome, idiopathic short stature, and short stature from chronic kidney disease. Daily injection has been the main burden of somatropin therapy, particularly for paediatric patients who may require years of treatment. This has driven the development of once-weekly alternatives (somatrogon and somapacitan), which are gradually changing the treatment landscape. Annual treatment costs remain substantial, and concerns about misuse in anti-ageing and performance enhancement contexts are ongoing.

Tesamorelin

Approved
GHRH Analogue

Tesamorelin is marketed as Egrifta SV (approved November 2010) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. In clinical trials, it reduced visceral fat by approximately 15% compared to a 5% increase with placebo, and this reduction was sustained with continued treatment. Tesamorelin occupies a unique niche — it is the only approved GHRH analogue and the only medication specifically approved for HIV-associated lipodystrophy. Beyond its approved indication, it has attracted research interest for potential effects on liver fat, cognitive function, and peripheral neuropathy. Fat reduction reverses when treatment stops, and it is not approved for general weight loss or body composition purposes.

Somatrogon

Approved
Long-Acting Growth Hormone

Somatrogon is marketed as Ngenla (approved June 2023) for paediatric growth hormone deficiency in children aged 3 years and older. In the pivotal trial, once-weekly somatrogon produced growth rates equivalent to daily somatropin injections (10.1 cm/year versus 9.8 cm/year), confirming that reducing injection frequency does not compromise growth outcomes. Ngenla represents a meaningful advance for paediatric patients and their families, reducing injections from 365 to 52 per year. Treatment adherence has been a persistent challenge with daily growth hormone, and weekly dosing is expected to improve long-term outcomes through better compliance. Somatrogon competes directly with somapacitan (Sogroya), the other approved weekly growth hormone, creating a new generation of less burdensome treatment options.