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

Phase 3

Recruiting

• Conditions: Obesity; Overweight; Type 2 Diabetes
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT06972472
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Study First Posted: 2025-05-15
• Study Start: 2025-05-19
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-08
• Last Update Posted: 2025-10-09
• Primary Completion: 2027-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron Dose 1	Orforglipron	Participants will receive orforglipron orally
Orforglipron Dose 2	Orforglipron	Participants will receive orforglipron orally
Orforglipron Dose 3	Orforglipron	Participants will receive orforglipron orally
Orforglipron Dose 4	Orforglipron	Participants will receive orforglipron orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline up to 72 weeks
Change from Baseline in HbA1c at Week 72	Baseline, Week 72
Change from Baseline in Fasting Glucose	Baseline up to 72 weeks
Percentage of Participants Achieving HbA1c of <7.0%	Baseline up to 72 weeks
Percentage of Participants Achieving Weight Reduction of ≥5%	Baseline up to 72 weeks
Change from Baseline in Waist Circumference	Baseline up to 72 weeks
Change from Baseline in Body Max Index (BMI)	Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline up to 72 weeks
Percent Change from Baseline in Triglycerides	Baseline up to 72 weeks
Change from Baseline in EQ-5D-5L	Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron	Predose through Week 48

Trial Locations

Locations (88)

Novak Clinical Research - Tucson - North La Cholla Boulevard; 🇺🇸 Tucson, Arizona, United States

Norcal Endocrinology & Internal Medicine; 🇺🇸 San Ramon, California, United States

Southern California Clinical Research; 🇺🇸 Santa Ana, California, United States

Care Access - Thousand Oaks; 🇺🇸 Thousand Oaks, California, United States

Accel Research Sites - DeLand Clinical Research Unit; 🇺🇸 DeLand, Florida, United States

Innovation Medical Research Center - Fort Lauderdale; 🇺🇸 Fort Lauderdale, Florida, United States

Encore Medical Research; 🇺🇸 Hollywood, Florida, United States

West Orange Endocrinology P.A.; 🇺🇸 Ocoee, Florida, United States

Care Access - Tampa; 🇺🇸 Tampa, Florida, United States

Accel Research Sites - NeuroStudies Clinical Research Unit; 🇺🇸 Decatur, Georgia, United States

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