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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

NCTNCT06993792 (opens ClinicalTrials.gov in a new tab)Other id27266Other id2025-521098-14-00Other idJ2A-MC-GZPOOther idJ2A-MC-GZP1

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
1,400 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
7 countries

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

Start
15 May 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
First posted
29 May 2025
Last update posted
31 Jul 2026
Conditions
Obesity · Overweight · Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

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

    NCT06993792

    15 May 2025 to est. Aug 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • OrforglipronDrug
  • PlaceboDrug

Arms10

  • Experimental

    Orforglipron Dose 1 (Study GZP1)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 2 (Study GZP1)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 3 (Study GZP1)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 4 (Study GZP1)

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo (Study GZP1)

    Participants will receive placebo orally

  • Experimental

    Orforglipron Dose 1 (Study GZP2)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 2 (Study GZP2)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 3 (Study GZP2)

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 4 (Study GZP2)

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo (Study GZP2)

    Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Allocated to Each Study

    Time frame · Baseline to Week 4

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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