Retatrutide has been evaluated in multiple clinical trials across Phase 1, Phase 2, and Phase 3 development stages. Prominently sponsored by Eli Lilly and Company alongside Hudson Biotech, these investigations target primary conditions including obesity, overweight, type 2 diabetes mellitus, and metabolic dysfunction-associated steatotic liver disease, while also evaluating comorbidities such as chronic kidney disease and chronic low back pain. Active, recruiting, and completed studies—including NCT07232719, NCT06662383, and NCT05936151—assess the comparative efficacy, safety, and glycemic response of once-weekly administration. Together, these clinical efforts demonstrate a broad evaluation of retatrutide across varied metabolic disorders and healthy participant cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07165028 | RECRUITING | Metabolic Dysfunction-Associated Steatotic Liver Disease |
Eli Lilly and Company |
2025-10-15 | PHASE3 |
| NCT06383390 | ACTIVE_NOT_RECRUITING | Atherosclerotic Cardiovascular Disease (ASCVD); Chronic Kidney Disease (CKD) |
Eli Lilly and Company |
2024-04-30 | PHASE3 |
| NCT07357415 | ACTIVE_NOT_RECRUITING | Obesity; Overweight |
Eli Lilly and Company |
2026-01-24 | PHASE3 |
| NCT06859268 | ACTIVE_NOT_RECRUITING | Obesity |
Eli Lilly and Company |
2025-03-05 | PHASE3 |
| NCT07035093 | ACTIVE_NOT_RECRUITING | Obesity; Overweight; Chronic Low Back Pain (CLBP) |
Eli Lilly and Company |
2025-05-29 | PHASE3 |
| NCT07232719 | ACTIVE_NOT_RECRUITING | Obesity; Overweight |
Eli Lilly and Company |
2025-11-17 | PHASE3 |
| NCT07467447 | RECRUITING | Obesity |
Hudson Biotech |
2026-02-15 | PHASE2 |
| NCT06982859 | ACTIVE_NOT_RECRUITING | Diabetes Mellitus; Insulin Sensitivity |
Eli Lilly and Company |
2025-06-02 | PHASE1 |
| NCT06662383 | ACTIVE_NOT_RECRUITING | Obesity |
Eli Lilly and Company |
2024-11-01 | PHASE3 |
| NCT06297603 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes |
Eli Lilly and Company |
2024-03-15 | PHASE3 |
| NCT06260722 | ACTIVE_NOT_RECRUITING | Diabetes Mellitus, Type 2 |
Eli Lilly and Company |
2024-02-21 | PHASE3 |
| NCT05929079 | COMPLETED | Type 2 Diabetes; Obesity; Overweight; Obstructive Sleep Apnea |
Eli Lilly and Company |
2023-07-11 | PHASE3 |
| NCT06982846 | COMPLETED | Type 2 Diabetes Mellitus |
Eli Lilly and Company |
2025-06-06 | PHASE1 |
| NCT05882045 | COMPLETED | Obesity; Cardiovascular Diseases |
Eli Lilly and Company |
2023-05-30 | PHASE3 |
| NCT05929066 | COMPLETED | Obesity; Overweight; Osteoarthritis, Knee; Obstructive Sleep Apnea |
Eli Lilly and Company |
2023-07-10 | PHASE3 |
| NCT06354660 | COMPLETED | Diabetes Type 2 |
Eli Lilly and Company |
2024-04-10 | PHASE3 |
| NCT05931367 | COMPLETED | Obesity; Overweight; Osteo Arthritis Knee |
Eli Lilly and Company |
2023-08-01 | PHASE3 |
| NCT05936151 | COMPLETED | Overweight or Obesity; CKD; Type 2 Diabetes |
Eli Lilly and Company |
2023-07-20 | PHASE2 |
| NCT06808802 | COMPLETED | Healthy |
Eli Lilly and Company |
2025-02-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-21)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Retatrutide (LY3437943) Solubility in DMSO
- Retatrutide (LY3437943) Stock Solution
- Retatrutide (LY3437943) Storage
- Retatrutide (LY3437943) Stability
- Retatrutide (LY3437943) CAS Number
- Retatrutide (LY3437943) Sigma (ATEH9A7417BB)? Try a better option.
- Retatrutide (LY3437943) MedChemExpress (HY-P3506)? Try a better option.
- Retatrutide (LY3437943) Cayman (39747)? Try a better option.
- Retatrutide (LY3437943) SDS|MSDS