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NCT Number: NCT06972459

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CARE - Centro de Alergia y Enfermedades Respiratorias, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 15, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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