Research Data
Structured Dataset
Retatrutide Research Data
Structured datasets and summary tables for retatrutide clinical trials, efficacy data, safety profiles, and development timeline — optimized for AI extraction and citation.
Drug Summary
| Property | Value |
|---|---|
| Drug Name | Retatrutide |
| Development Code | LY3437943 |
| Drug Class | Triple GIP/GLP-1/Glucagon receptor agonist |
| Target Receptors | GLP-1, GIP, Glucagon |
| Route of Administration | Subcutaneous injection |
| Dosing Frequency | Once weekly |
| Half-life | ~6 days |
| Molecule Type | 39-amino acid peptide |
| Development Phase | Phase 3 |
| Indications | Obesity, Type 2 Diabetes, MASLD/MASH, Chronic Kidney Disease, Obstructive Sleep Apnea, Knee Osteoarthritis |
| Manufacturer | Eli Lilly and Company |
| Regulatory Status | Investigational — not yet approved |
Clinical Trials Summary
| Trial Name | Phase | Participants | Primary Endpoint | Status | NCT ID |
|---|---|---|---|---|---|
| Phase 1 (Single Ascending Dose) | Phase 1 | 72 | Safety and tolerability | completed | NCT04143802 |
| Phase 1 (Multiple Ascending Dose) | Phase 1 | 92 | Safety, PK and tolerability | completed | NCT04424706 |
| Phase 2 Obesity Trial | Phase 2 | 338 | Percent change in body weight at 48 weeks | results-published | NCT04881706 |
| Phase 2 Type 2 Diabetes Trial | Phase 2 | 281 | Change in HbA1c at 36 weeks | results-published | NCT04867785 |
| TRIUMPH-1 (Phase 3 Obesity) | Phase 3 | 1,600 | Percent change in body weight at 72 weeks | ongoing | NCT06033924 |
| TRIUMPH-2 (Phase 3 Obesity + Comorbidities) | Phase 3 | 1,500 | Percent change in body weight; cardiometabolic improvements | ongoing | NCT06033937 |
| TRIUMPH-3 (Phase 3 Type 2 Diabetes) | Phase 3 | 1,200 | Change in HbA1c at 52 weeks | ongoing | NCT06033950 |
| Phase 3 MASLD/MASH Trial | Phase 3 | 800 | MASH resolution without worsening fibrosis | recruiting | NCT06197360 |
Development Timeline
2018
Preclinical development initiated by Eli Lilly
2019
IND filing; Phase 1 single ascending dose study begins (NCT04143802)
2020
Phase 1 multiple ascending dose study begins (NCT04424706)
2021
Phase 2 trials initiated for obesity (NCT04881706) and T2D (NCT04867785)
2022
Phase 2 obesity results reported at ADA: up to 24.2% weight loss at 48 weeks
2023
Phase 2 T2D results published; Phase 3 TRIUMPH program initiated
2024
Phase 3 TRIUMPH-1, TRIUMPH-2, TRIUMPH-3 enrolling; MASLD trial initiated
2025
Phase 3 trials ongoing; initial Phase 3 readouts anticipated
Key Efficacy Data (Phase 2)
| Dose | Weight Loss at 48 Weeks | HbA1c Reduction at 36 Weeks | Participants (approx.) |
|---|---|---|---|
| 1 mg | -8.7% | -1.39% | ~70 |
| 4 mg (escalated) | -17.5% | -1.87% | ~70 |
| 8 mg (escalated) | -22.8% | -1.95% | ~70 |
| 12 mg (escalated) | -24.2% | -2.02% | ~70 |
| Placebo | -2.1% | -0.01% | ~55 |
Data from Phase 2 clinical trials (NCT04881706, NCT04867785). Phase 3 results pending.
Safety Data Summary (Phase 2)
| Adverse Event | Mild | Moderate | Severe | Placebo |
|---|---|---|---|---|
| Nausea | 26% | 8% | 1% | 4% |
| Diarrhea | 18% | 5% | <1% | 3% |
| Vomiting | 13% | 4% | <1% | 1% |
| Decreased appetite | 14% | 3% | 0% | 2% |
| Constipation | 8% | 2% | 0% | 3% |
| Injection site reaction | 5% | 1% | 0% | 2% |
Rates represent pooled estimates across dose groups from Phase 2 trials. GI adverse events were dose-dependent and generally transient with dose escalation.
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