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Retatrutide for weight loss in adults with overweight or obesity (without type 2 diabetes)

A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial

Phase 3 Interventional Eli Lilly and Company · NCT07357415

This trial tests different retatrutide dose‑escalation schedules to see if they are safe and help adults with overweight or obesity (without type 2 diabetes) lose weight over about 113 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations35 sites (Phoenix, Arizona and 34 other locations)
Trial IDNCT07357415 on ClinicalTrials.gov

What this trial studies

This is a Phase 3 interventional trial testing different dose escalation schemes of retatrutide in adults who have obesity or overweight but do not have type 2 diabetes. Eligible participants must meet BMI thresholds (≥30 kg/m2, or ≥27 kg/m2 with a weight‑related condition) and have had at least one prior unsuccessful dieting attempt. Participants receive retatrutide and are followed for safety and weight outcomes over roughly 113 weeks. The study will compare dosing strategies and monitor adverse events to define an effective and tolerable regimen.

Who should consider this trial

Good fit: Adults without type 2 diabetes who have a BMI ≥30 kg/m2 (or ≥27 kg/m2 with a weight‑related condition), who have tried and not maintained weight loss through dieting, and who meet the study's medical eligibility criteria are the ideal candidates.

Not a fit: People with type 1 or type 2 diabetes, recent large weight change, prior or planned bariatric surgery, certain cardiac conditions, a personal or family history of medullary thyroid carcinoma or MEN‑2, or recent pancreatitis would not be expected to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, the regimen could offer a new medication option that produces substantial, durable weight loss with an acceptable safety profile for people without type 2 diabetes.

How similar studies have performed: Earlier‑phase trials of retatrutide and other multi‑agonist agents have shown large weight‑loss signals, but Phase 3 confirmation and long‑term safety data are still being established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a Body Mass Index (BMI) at screening

  * ≥ 30 kilogram per square meter (kg/m2) OR
  * ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
* Have at least one unsuccessful attempt to lose weight by dieting

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening
* Have a prior or planned surgical treatment for obesity
* Have type 1 diabetes or type 2 diabetes
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had within the past 90 days before screening:

  * heart attack
  * stroke
  * hospitalization for unstable angina or heart failure
* Have New York Heart Association Functional Classification Class IV congestive heart failure
* Have a history of chronic or acute pancreatitis
* Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening

Where this trial is running

Phoenix, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.