A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

Lilly

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972459

27361

J2A-MC-GZPO (Other Identifier)

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

J2A-MC-GZP1 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding 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) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:

  • hypertension
  • dyslipidemia
  • obstructive sleep apnea, or
  • cardiovascular disease

• Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion criteria

• Have type 1 diabetes, type 2 diabetes, or any other types of 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

---

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