Enobosarm: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข3 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Oral formulation. Specific storage conditions for the clinical trial formulation have not been publicly disclosed. Small molecules typically stored at controlled room temperature (15-30 degrees C) protected from moisture.
Protocol Quick-Reference
Muscle preservation during GLP-1 receptor agonist therapy
Dosing
Amount
3 mg orally once daily
Frequency
Once daily
Duration
16-72 weeks (trial dependent)
Step-wise Titration
Administration
Route
OralSchedule
N/A (oral)
Timing
Once daily oral administration; no specific timing requirement reported
Cycle
Duration
Ongoing (with GLP-1 co-administration)
Repeatable
Yes
Preparation & Storage
โ Ready-to-use โ no reconstitution required
Storage: Controlled room temperature (15-30 degrees C)
โ๏ธ Suggested Bloodwork (5 tests)
When:
Why:
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๐ก Key Considerations
- โInvestigational drug - not approved by any regulatory authority
- โFDA confirmed 3 mg as acceptable dosage
- โOral administration (no injection required)
- โALT elevations have been observed; liver monitoring recommended
- โNot available commercially; clinical trial access only
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Muscle Preservation with GLP-1 Therapy (QUALITY Trial) | 3 mg orally once daily, taken concurrently with semaglutide (Wegovy) for weight loss in older adults with obesity or overweight. | Once daily oral administration | 16 weeks (QUALITY trial duration) with 12-week maintenance extension | FDA confirmed 3 mg as an acceptable dosage for further development. The 3 mg dose produced 0% lean mass loss and 100% fat mass loss when combined with semaglutide. |
| Lean Body Mass in Healthy Elderly (Phase 2) | 1 mg or 3 mg orally once daily. Both doses produced dose-dependent lean mass gains over 12 weeks. | Once daily oral administration | 12 weeks | The 3 mg dose produced greater lean mass gains and physical function improvement. ALT elevations were more common at 3 mg (20.8% in cancer trial). |
| PLATEAU Trial with Tirzepatide (Planned) | 3 mg orally once daily, taken concurrently with tirzepatide for weight loss in patients with obesity. | Once daily oral administration | 72 weeks | Phase 2b PLATEAU trial planned for approximately 180 patients. Primary endpoint is percent change in total body weight at 72 weeks. Planned enrollment Q1 2026. |
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๐Reconstitution Instructions
Enobosarm is an oral small molecule (not a peptide requiring reconstitution). It is administered as a capsule or tablet and does not require injection or reconstitution.
๐งStorage Requirements
Oral formulation. Specific storage conditions for the clinical trial formulation have not been publicly disclosed. Small molecules typically stored at controlled room temperature (15-30 degrees C) protected from moisture.
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Investigational Status#
Enobosarm (Ostarine, GTx-024, MK-2866) is an investigational oral SARM that has not received regulatory approval from any authority. All dosing information is derived from clinical trial protocols and published study results. Enobosarm is not commercially available as a pharmaceutical product.
Important: "Ostarine" or "MK-2866" products sold online as supplements or research chemicals are not pharmaceutical-grade, are not FDA-approved, and may contain contaminants, incorrect doses, or undisclosed substances. The FDA has issued warning letters to companies selling SARMs.
Clinical Trial Dosing#
QUALITY Trial (Phase 2b -- Obesity + Semaglutide)#
The most relevant dosing data for the current obesity indication:
| Parameter | Details |
|---|---|
| Dose | 3 mg or 6 mg orally, once daily |
| Co-medication | Semaglutide (Wegovy) |
| Population | Adults >60 years with overweight or obesity |
| Duration | 16 weeks + 12-week maintenance extension |
| Outcome | 0% lean mass loss, 100% fat mass at 3 mg |
The FDA has confirmed 3 mg as the acceptable dosage for further clinical development.
Phase 2 -- Healthy Elderly (Dalton et al., 2011)#
| Dose | Lean Mass Change | Stair Climb | ALT Elevation |
|---|---|---|---|
| Placebo | Reference | Reference | Reference |
| 1 mg daily | Increased | Improved | Low incidence |
| 3 mg daily | Greater increase | Greater improvement | ~6.7% overall |
Phase 2 -- Cancer Cachexia (Dobs et al., 2013)#
| Dose | Lean Mass Gain (median) | ALT Elevation |
|---|---|---|
| 1 mg daily | 1.5 kg by day 113 | Lower incidence |
| 3 mg daily | 1.0 kg by day 113 | 20.8% |
Planned PLATEAU Trial (with Tirzepatide)#
| Parameter | Details |
|---|---|
| Dose | 3 mg orally, once daily |
| Co-medication | Tirzepatide |
| Population | ~180 patients with obesity (aged >65 and <65) |
| Duration | 72 weeks |
| Primary endpoint | Percent change in total body weight |
| Planned start | Q1 2026 |
Administration#
Route#
- Oral: Capsule or tablet, once daily
- No injection, reconstitution, or cold chain storage required
- This represents a practical advantage over injectable muscle-preserving therapies (bimagrumab, trevogrumab, apitegromab)
Monitoring Requirements#
Monitoring is recommended based on adverse events observed in clinical trials:
| Test | Rationale | Timing |
|---|---|---|
| ALT/AST | Liver enzyme elevations observed | Baseline, periodic |
| Lipid panel | HDL decreases reported | Baseline, periodic |
| Testosterone/SHBG | Hormone suppression documented | Baseline, periodic |
| DXA scan | Lean mass and fat mass tracking | Baseline, endpoint |
| Complete blood count | General safety | Baseline, as indicated |
Dose Selection Rationale#
The 3 mg dose was selected for further development based on:
- Efficacy: Produced meaningful lean mass gains across multiple trials
- QUALITY results: Achieved 0% lean mass loss composition with semaglutide
- Tolerability: Generally well tolerated with manageable side effects
- FDA confirmation: Accepted as the development dose for the obesity indication
- Safety margin: ALT elevations less frequent at 3 mg vs higher doses in earlier studies
Context: Oral vs Injectable Muscle-Preserving Therapies#
| Parameter | Enobosarm | Bimagrumab | Trevogrumab | Apitegromab |
|---|---|---|---|---|
| Route | Oral daily | IV Q4W | SC | SC |
| Class | SARM | ActRII antibody | Anti-myostatin mAb | Anti-latent myostatin |
| Convenience | High (oral) | Low (IV) | Moderate (SC) | Moderate (SC) |
| Cold chain | No | Yes | Yes | Yes |
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.