A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight

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

  • Obesity
  • Overweight

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