A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06993792

J2A-MC-GZP2 (Other Identifier)

27266

J2A-MC-GZPO (Other Identifier)

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

J2A-MC-GZP1 (Other Identifier)

Details and patient eligibility

About

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

There are no specific eligibility criteria for the Master Protocol.

• See study GZP1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes
• See study GZP2 for eligibility criteria relevant to participants with type 2 diabetes

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 10 patient groups, including a placebo group

Orforglipron Dose 1 (Study GZP1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 2 (Study GZP1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 3 (Study GZP1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 4 (Study GZP1)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (Study GZP1)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo

Orforglipron Dose 1 (Study GZP2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 2 (Study GZP2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 3 (Study GZP2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Orforglipron Dose 4 (Study GZP2)

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo (Study GZP2)

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo