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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 3b
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retatrutide Dose Escalation 1 		Participants will receive retatrutide subcutaneously (SC)
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Experimental
Retatrutide Dose Escalation 2 		Participants will receive retatrutide SC
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Experimental
Retatrutide Dose Escalation 3 		Participants will receive retatrutide SC
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943

Recruiting Locations

Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts 02115
Contact:
617-278-0454

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.