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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Orforglipron Dose 1 |
Participants will receive orforglipron orally |
|
|
Experimental Orforglipron Dose 2 |
Participants will receive orforglipron orally |
|
|
Experimental Orforglipron Dose 3 |
Participants will receive orforglipron orally |
|
|
Experimental Orforglipron Dose 4 |
Participants will receive orforglipron orally |
|
|
Placebo Comparator Placebo |
Participants will receive placebo orally |
|
Recruiting Locations
More Details
- NCT ID
- NCT06972472
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company