Research Use Only: This information is for research purposes only. Always consult qualified professionals and follow institutional protocols for research applications.
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Clinical Trial Dosage Protocols
Based on Phase 2 and Phase 3 clinical trials, Retatrutide dosing follows a careful escalation protocol to minimize adverse events while achieving therapeutic efficacy.
Starting Dose Recommendations from Clinical Trials:
- Recommended starting dose: 1mg once weekly for 4 weeks
- Clinical trial starting dose: Many trials started at 2mg, but expect increased side effects
- Administration: Subcutaneous injection, same day each week
- Timing: Can be taken with or without food
- Note: Starting at 1mg reduces gastrointestinal side effects compared to 2mg starts
Titration Schedule (Clinical Trial Protocol):
| Week |
Dose |
Purpose |
Notes |
| 1-4 |
1mg |
Initiation |
Recommended starting dose, assess tolerance |
| 5-8 |
2mg |
First escalation |
Monitor for GI side effects, therapeutic effects begin |
| 9-12 |
4mg |
Second escalation |
Significant therapeutic effects emerge |
| 13-16 |
8mg |
Target dose (medium) |
Optimal efficacy for most participants |
| 17-20 |
12mg |
Maximum dose |
Reserved for participants requiring higher doses |
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Clinical Trial Recommendations
Key Clinical Trial Findings:
- Trial Starting Doses: Many clinical trials started participants at 2mg weekly, but this resulted in higher side effect rates
- Recommended Approach: Starting at 1mg reduces initial side effects while still providing therapeutic benefit
- Individual Variation: Some participants achieved maximum benefit at 4mg, others required 8-12mg
- Dose Delays: If side effects occur, trials allowed dose delays of 1-2 weeks before escalation
- Dose Reduction: Up to 30% of participants required dose reduction during trials
Critical Protocol Note: While clinical trials often started at 2mg, research teams now recommend starting at 1mg to improve tolerability. Expect increased nausea, vomiting, and diarrhea if starting at 2mg without proper titration.
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Adverse Events from Clinical Trials
The following side effects were documented in Phase 2 and Phase 3 clinical trials. Side effects were generally dose-dependent and most common during dose escalation periods.
Common Side Effects (>10% of participants):
- Nausea (42-48%)
- Diarrhea (31-36%)
- Vomiting (24-29%)
- Decreased appetite (22-27%)
- Constipation (19-23%)
- Abdominal pain (16-20%)
- Fatigue (14-18%)
- Injection site reactions (12-15%)
Less Common Side Effects (1-10%):
- Headache (8-12%)
- Dizziness (6-9%)
- Gastroesophageal reflux (5-8%)
- Dyspepsia (4-7%)
- Flatulence (3-6%)
- Burping/eructation (3-5%)
- Insomnia (2-4%)
- Hair loss (2-3%)
Serious Adverse Events (Rare, <1%):
- Pancreatitis: 3 cases reported across all trials (>5000 participants)
- Gallbladder disorders: Increased risk with rapid weight loss
- Severe dehydration: Due to persistent vomiting in some cases
- Hypoglycemia: Primarily in participants with diabetes
Note: Most serious adverse events were associated with rapid dose escalation or inadequate monitoring.
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Clinical Trial Side Effect Management
Trial Protocols for Managing Side Effects:
- Nausea/Vomiting: Dose delay, anti-emetic medication, dietary modifications
- Diarrhea: Dietary fiber adjustment, loperamide if severe, hydration monitoring
- Injection Site Reactions: Rotation of injection sites, ice application
- Persistent Side Effects: Dose reduction or temporary discontinuation allowed
Clinical Trial Outcome: With proper dose escalation and side effect management, 85-90% of participants were able to complete the full trial duration. Most side effects were transient and resolved within 2-4 weeks of dose stabilization.
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Clinical Trial Documentation
The following published clinical trials provide the source data for the dosage and side effect information presented above:
Important Research Notes:
- Current Status: Retatrutide is primarily in Phase 2 trials, with Phase 3 trials ongoing
- Primary Study: The NEJM Phase 2 trial demonstrated up to 24.2% weight reduction at 48 weeks
- Trial Protocols: Phase 2 trials tested various starting doses from 1mg to 12mg weekly
- Regulatory Status: Retatrutide is investigational and not approved for therapeutic use
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