A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes

Purpose

The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.

Conditions

  • Obesity
  • Overweight
  • Type 2 Diabetes

Eligibility

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

Inclusion Criteria

  • Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening - Have type 2 diabetes - Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening - Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria

  • Have type 1 diabetes - Have an unstable body weight within 90 days prior to screening - Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening - Have acute or chronic hepatitis or pancreatitis - Are taking other medications or alternative remedies to manage weight loss

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
Orforglipron Dose 1
Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Experimental
Orforglipron Dose 2
Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Experimental
Orforglipron Dose 3
Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Experimental
Orforglipron Dose 4
Participants will receive orforglipron orally
  • Drug: Orforglipron
    Administered orally
    Other names:
    • LY3502970
Placebo Comparator
Placebo
Participants will receive placebo orally
  • Drug: Placebo
    Administered orally

Recruiting Locations

More Details

NCT ID
NCT06972472
Status
Active, not recruiting
Sponsor
Eli Lilly and Company