Ibutamoren (MK-677): Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข3 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: In clinical trials, ibutamoren capsules were stored at controlled room temperature (15-30 degrees C / 59-86 degrees F) in original containers protected from moisture and light. As an unapproved investigational compound, no commercial storage guidelines exist.
Protocol Quick-Reference
Growth hormone secretion and body composition
Dosing
Amount
25 mg
Frequency
Once daily
Duration
12 months (primary trial)
Administration
Route
OralTiming
Administered as an oral capsule once daily. Some protocols specify evening administration to augment the natural nocturnal GH pulse.
Cycle
Duration
12 months (Nass et al. trial); up to 2 years studied
Repeatable
Yes
โ๏ธ Suggested Bloodwork (4 tests)
IGF-1
When: Baseline, 4 weeks, and every 3 months
Why: Monitor growth hormone axis response
Fasting glucose and HbA1c
When: Baseline and every 3 months
Why: Monitor insulin resistance and glucose elevation
Fasting insulin
When: Baseline and 3 months
Why: Assess insulin sensitivity changes
Echocardiogram or BNP
When: Baseline (in at-risk populations)
Why: Screen for cardiac risk given CHF signal in hip fracture trial
๐ก Key Considerations
- โNot FDA-approved: development was discontinued due to safety concerns
- โHeart failure risk identified in elderly populations (6.5% vs 1.7% placebo in hip fracture trial)
- โCauses insulin resistance and elevated fasting glucose; monitor metabolic parameters closely
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Body Composition / Sarcopenia (Clinical Trial Protocol) | 25 mg oral once daily. This was the standard dose used in the Nass et al. (2008) body composition trial in healthy elderly adults aged 60-81 years. | Once daily oral administration | 12 months in the primary trial; 2-year crossover design | Not an approved medication. 25 mg daily was the most commonly studied dose in clinical trials. Produced sustained GH and IGF-1 elevation over 12 months. |
| Hip Fracture Recovery (Clinical Trial Protocol) | 25 mg oral once daily. Used in the Adunsky et al. trial in elderly patients recovering from hip fracture surgery. | Once daily oral administration | 24 weeks (trial stopped early due to safety concerns) | Trial was terminated early due to increased congestive heart failure rates in the ibutamoren group (6.5% vs 1.7% placebo). |
| Catabolic State / Nitrogen Wasting (Clinical Trial Protocol) | 25 mg oral once daily. Murphy et al. (1998) evaluated MK-677 for reversing diet-induced catabolism. | Once daily oral administration | Short-term (days to weeks) | Demonstrated reversal of nitrogen wasting in calorie-restricted healthy volunteers. |
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๐Reconstitution Instructions
Not applicable. Ibutamoren is an orally administered small molecule, not an injectable peptide. In clinical trials, it was supplied as oral capsules requiring no reconstitution or preparation.
๐งStorage Requirements
In clinical trials, ibutamoren capsules were stored at controlled room temperature (15-30 degrees C / 59-86 degrees F) in original containers protected from moisture and light. As an unapproved investigational compound, no commercial storage guidelines exist.
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Important Disclaimer#
Ibutamoren (MK-677) is not an approved medication. It has never received regulatory approval from the FDA or any other agency. The dosing information below is derived exclusively from published clinical trial protocols and is provided for educational and research reference purposes only.
Clinical Trial Dosing#
Standard Research Dose#
The most consistently used dose across clinical trials was 25 mg orally once daily. This dose was selected based on early dose-finding studies that identified 25 mg as the optimal balance between GH/IGF-1 stimulation and tolerability.
Dose-Response Relationship#
Early phase 1 studies by Merck evaluated multiple dose levels:
| Dose | GH Response | IGF-1 Response | Tolerability |
|---|---|---|---|
| 5 mg daily | Modest increase | Minimal | Well tolerated |
| 10 mg daily | Moderate increase | Moderate increase | Well tolerated |
| 25 mg daily | Robust increase (~97%) | Significant increase | Acceptable; appetite increase, mild edema |
| 50 mg daily | Not systematically studied in long-term trials | Not systematically studied | Not established |
The 25 mg dose was carried forward into all major phase 2 trials based on this dose-response profile.
Administration Timing#
In clinical trials, MK-677 was typically administered once daily. Some protocols specified evening administration based on the rationale of augmenting the natural nocturnal GH pulse, though the specific timing varied across studies.
Key Clinical Trial Protocols#
Nass et al. (2008) - Body Composition in Healthy Elderly#
- Population: 65 healthy adults aged 60-81 years
- Dose: 25 mg oral once daily
- Duration: 2-year modified crossover design (primary endpoint at 12 months)
- Results: Fat-free mass increased by 1.6 kg vs placebo at 12 months; GH and IGF-1 increased to levels typical of young adults
Hip Fracture Recovery Trial#
- Population: 123 elderly patients post hip fracture surgery
- Dose: 25 mg oral once daily
- Duration: Planned 24 weeks; stopped early
- Results: Trial terminated due to higher congestive heart failure rate in the ibutamoren group
Murphy et al. (1998) - Catabolic State#
- Population: Healthy volunteers on calorie-restricted diets
- Dose: 25 mg oral once daily
- Duration: Short-term
- Results: Reversed diet-induced nitrogen wasting
Oral Administration#
Ibutamoren's primary advantage over peptide-based GH secretagogues is its oral bioavailability. In clinical trials, it was administered as a capsule without food restrictions, though some early studies noted that administration with food did not significantly alter absorption.
No Reconstitution Required#
As a small molecule drug administered orally in capsule form, ibutamoren requires no reconstitution, dilution, or injection preparation. This distinguishes it from peptide-based GH secretagogues (GHRP-6, GHRP-2, hexarelin, sermorelin) that require reconstitution with bacteriostatic water and subcutaneous injection.
Storage#
Clinical trial supplies were stored at controlled room temperature. As ibutamoren is not commercially available as an approved medication, no official storage guidelines exist from regulatory agencies.
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.