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

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06993792

Enrollment

1400

Registered

2025-05-29

Start date

2025-05-15

Completion date

2027-08-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Type 2 Diabetes

Brief summary

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).

Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Phase 3b

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Number of Participants Allocated to Each Study	Baseline to Week 4

Countries

Argentina, China, Czechia, Germany, Japan, Puerto Rico, United States

Contacts

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026