NCT07357415

Brief Summary

The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
31mo left

Started Jan 2026

Typical duration for phase_3 obesity

Geographic Reach
3 countries

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Nov 2028

First Submitted

Initial submission to the registry

January 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 24, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

January 16, 2026

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 104

Secondary Outcomes (7)

  • Change from Baseline in Waist Circumference

    Baseline, Week 104

  • Percent Change from Baseline in Triglycerides

    Baseline, Week 104

  • Change from Baseline in Systolic Blood Pressure

    Baseline, Week 104

  • Percent Change from Baseline in High Sensitivity C-Reactive Protein

    Baseline, Week 104

  • Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score

    Baseline, Week 104

  • +2 more secondary outcomes

Study Arms (3)

Retatrutide Dose Escalation 1

EXPERIMENTAL

Participants will receive retatrutide subcutaneously (SC)

Drug: Retatrutide

Retatrutide Dose Escalation 2

EXPERIMENTAL

Participants will receive retatrutide SC

Drug: Retatrutide

Retatrutide Dose Escalation 3

EXPERIMENTAL

Participants will receive retatrutide SC

Drug: Retatrutide

Interventions

Administered SC

Also known as: LY3437943
Retatrutide Dose Escalation 1Retatrutide Dose Escalation 2Retatrutide Dose Escalation 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Arizona Research Center

Phoenix, Arizona, 85053, United States

RECRUITING

Care Access - Huntington Beach

Huntington Beach, California, 92648, United States

RECRUITING

Los Angeles Institute for Metabolic Research

Los Angeles, California, 90015, United States

RECRUITING

New Horizon Research Center

Miami, Florida, 33165, United States

RECRUITING

Encore Medical Research - Weston

Weston, Florida, 33331, United States

RECRUITING

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, 96817, United States

RECRUITING

L-MARC Research Center

Louisville, Kentucky, 40213, United States

RECRUITING

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, 02115, United States

RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

RECRUITING

NYC Research INC

Long Island City, New York, 11106, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Care Access - Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

New Phase Research and Development

Knoxville, Tennessee, 37909, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

Cedar Health Research - Texas Native Health

Dallas, Texas, 75235, United States

RECRUITING

Cedar Health Research

Dallas, Texas, 75251, United States

RECRUITING

Cedar Health Research - Fort Worth

Fort Worth, Texas, 76132, United States

RECRUITING

Advanced Research Institute

Ogden, Utah, 84405, United States

RECRUITING

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

RECRUITING

CAMC Institute for Academic Medicine

Charleston, West Virginia, 25304, United States

RECRUITING

Cicemo Srl

Buenos Aires, 1424, Argentina

RECRUITING

CARDIAMET Investigaciones Médicas

Buenos Aires, C1014ACP, Argentina

RECRUITING

Stat Research S.A.

Buenos Aires, C1023AAB, Argentina

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

RECRUITING

Centro Médico Viamonte

Buenos Aires, C1120AAC, Argentina

RECRUITING

Aggarwal and Associates Limited

Brampton, L6T 0G1, Canada

RECRUITING

Med Trust Research

Courtice, L1E 2J5, Canada

RECRUITING

Winterberry Research Inc.

Hamilton, L8J 0B6, Canada

RECRUITING

Diex Recherche Inc. Division Joliette

Joliette, J6E 6A9, Canada

RECRUITING

Milestone Research Inc.

London, N5W 6A2, Canada

RECRUITING

Diex Recherche Inc. Division Quebec

Québec, G1V 4T3, Canada

RECRUITING

Diex Recherche Inc. Division Sherbrooke

Sherbrooke, J1L 0H8, Canada

RECRUITING

Canadian Phase Onward

Toronto, M3J 0K2, Canada

RECRUITING

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, M9V 4B4, Canada

RECRUITING

C.I.C. Mauricie inc.

Trois-Rivières, G8T 7A1, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

retatrutide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

Physicians interested in becoming principal investigators please contact

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase 3b
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 22, 2026

Study Start

January 24, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
More information

Locations