A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Phase 3

Active, not recruiting

• Conditions: Obesity; Overweight; Overweight or Obesity
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT05869903
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-22
• Study Start: 2023-06-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Have a BMI

  • ≥30.0 kilogram/square meter (kg/m²),

  • ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

    • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

• Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
• Have had a history of chronic or acute pancreatitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron Dose 1	Orforglipron	Participants will receive orforglipron administered orally.
Orforglipron Dose 2	Orforglipron	Participants will receive orforglipron administered orally.
Orforglipron Dose 3	Orforglipron	Participants will receive orforglipron administered orally.
Placebo	Placebo	Participants will be given placebo.

Primary Outcome Measures

Name	Time	Method
Mean Percent Change from Baseline in Body Weight	Baseline to Week 72

Secondary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Waist Circumference	Baseline, Week 72
Mean Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 72
Mean Percent Change from Baseline in Fasting non-HDL Cholesterol	Baseline, Week 72
Mean Percent Change from Baseline in Fasting Triglycerides	Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %	Baseline, Week 72
Mean Change from Baseline in Fasting Glucose	Baseline, Week 72
Mean Percent Change from Baseline in Fasting Insulin	Baseline, Week 72
Mean Change from Baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 72
Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores	Baseline, Week 72

Trial Locations

Locations (138)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa; 🇺🇸 Chandler, Arizona, United States

Velocity Clinical Research, Huntington Park; 🇺🇸 Huntington Park, California, United States

Velocity Clinical Research, Westlake; 🇺🇸 Los Angeles, California, United States

East Coast Institute for Research, LLC; 🇺🇸 Macon, Georgia, United States

Cotton O'Neil Diabetes & Endocrinology; 🇺🇸 Topeka, Kansas, United States

SKY Integrative Medical Center/SKYCRNG; 🇺🇸 Ridgeland, Mississippi, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Velocity Clinical Research, Dallas; 🇺🇸 Dallas, Texas, United States

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas; 🇧🇷 Fortaleza, Ceará, Brazil

Quanta Diagnóstico e Terapia; 🇧🇷 Curitiba, Paraná, Brazil

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