A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee (ATTAIN-OA PAIN)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07153471

J2A-MC-GZPT (Other Identifier)

J2A-MC-GZT2 (Other Identifier)

27633

J2A-MC-GZT1 (Other Identifier)

2025-522631-34-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening

• Have tried at least once to lose weight through diet but were unsuccessful

• Have osteoarthritis of the knee and at least one of the following conditions:

  • Be over 50 years old
  • Have morning knee stiffness that lasts about 30 minutes
  • Have a crackling or grinding sound or feeling in the knee

Exclusion criteria

• Have gained or lost more than 11 pounds within 90 days prior to screening
• Have had a surgery for obesity or plan to have one in the next 18 months
• Have an active knee infection
• Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
• Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure
• Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 4 patient groups, including a placebo group

Orforglipron (GZT1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (GZT1)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo

Orforglipron (GZT2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (GZT2)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo