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

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Lilly

Status and phase

Not yet 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

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

Trial contacts and locations

89

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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