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

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972472

J2A-MC-GZP2 (Other Identifier)

27362

J2A-MC-GZPO (Other Identifier)

2025-521098-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Participation in the study will last about 18 months.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 5 patient groups, including a placebo group

Orforglipron Dose 1

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 2

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 3

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 4

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo