Clinical Trials

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)

Check the Retatrutide (LY3437943) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Retatrutide functions as a peptide triple agonist of the glucagon receptor (GCGR), glucagon-like peptide-1 receptor (GLP-1R), and glucose-dependent insulinotropic polypeptide receptor (GIPR), displaying potent activity at human GIPR, GLP-1R, and GCGR with EC50 values of 0.0643 nM, 0.775 nM, and 5.79 nM, respectively. Co-activation of these downstream receptor signaling pathways stimulates nutrient-induced insulin secretion, suppresses appetite, and increases energy expenditure, thereby driving significant body weight reduction and glycemic control in therapeutic contexts such as obesity, type 2 diabetes, and metabolic dysfunction-associated steatotic liver disease.

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>).

Note: Technical data last updated: Sep 1, 2026.