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Trial · Interventional

Active, not recruitingPhase 3Registry data

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

NCTNCT06972459 (opens ClinicalTrials.gov in a new tab)Other id27361Other id2025-521098-14-00Other idJ2A-MC-GZP1Other idJ2A-MC-GZPO
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
800 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
15 May 2025
Last update posted
29 Jul 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 ongoing

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

    A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

    NCT06972459

    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 main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms5

  • Experimental

    Orforglipron Dose 1

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 2

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 3

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron Dose 4

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo

    Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 72

Secondary outcomes(9)

  1. Percentage of Participants Achieving Weight Reduction of ≥5%

    Time frame · Baseline up to 72 weeks

  2. Change from Baseline in Waist Circumference

    Time frame · Baseline up to 72 weeks

  3. Change from Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 72

  4. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame · Baseline up to 72 weeks

  5. Percent Change from Baseline in Triglycerides

    Time frame · Baseline up to 72 weeks

  6. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline up to 72 weeks

  7. Change from Baseline in Fasting Glucose

    Time frame · Baseline up to 72 weeks

  8. Change from Baseline in EQ-5D-5L

    Time frame · Baseline, Week 72

  9. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron

    Time frame · Predose through Week 48

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
Inclusion Criteria: * Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * Have a history of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Have type 1 diabetes, type 2 diabetes, or any other types of 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

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