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

NCT05869903 · tracked via the Priya Life Science China tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2023-06-05

Last updated

2026-08-14

Condition(s) studied

ObesityOverweightOverweight or Obesity

Investigational drug(s) / intervention(s)

OrforglipronPlacebo

Orforglipron: Administered orally.

Placebo: Administered orally.

Study 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. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Percent Change From Baseline in Body Weight (Primary Treatment Period) — Baseline, Week 72
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

Trial sites (138)

Facility	City	Region
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa	Chandler	Arizona
Clinical Research Institute of Arizona (CRI) - Sun City West	Sun City West	Arizona
John Muir Physician Network Research Center	Concord	California
AMCR Institute	Escondido	California
NorCal Medical Research, Inc	Greenbrae	California
Velocity Clinical Research, Huntington Park	Huntington Park	California
Velocity Clinical Research, Westlake	Los Angeles	California
Catalina Research Institute, LLC	Montclair	California
Norcal Endocrinology & Internal Medicine	San Ramon	California
University Clinical Investigators, Inc.	Tustin	California
University of Colorado Anschutz Medical Campus	Aurora	Colorado
New Age Medical Research Corporation	Miami	Florida
South Broward Research	Miramar	Florida
Renstar Medical Research	Ocala	Florida
Jedidiah Clinical Research - Tampa - Bay Plaza	Tampa	Florida
Clinical Site Partners, LLC dba Flourish Research	Winter Park	Florida
Physicians Research Associates	Lawrenceville	Georgia
East Coast Institute for Research, LLC	Macon	Georgia
Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
East-West Medical Research Institute	Honolulu	Hawaii
Elite Clinical Trials	Blackfoot	Idaho
Cotton O'Neil Clinical Research Center	Topeka	Kansas
Cotton O'Neil Diabetes & Endocrinology	Topeka	Kansas
Pennington Biomedical Research Center	Baton Rouge	Louisiana
Care Access - Lake Charles	Lake Charles	Louisiana
MedStar Health Research Institute (MedStar Physician Based Research Network)	Hyattsville	Maryland
Endocrine and Metabolic Consultants	Rockville	Maryland
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
SKY Integrative Medical Center/SKYCRNG	Ridgeland	Mississippi
Las Vegas Medical Research	Las Vegas	Nevada
Long Island Cardiovascular Consultants	Lake Success	New York
Weill Cornell Medical College	New York	New York
Alliance for Multispecialty Research, LLC	Norman	Oklahoma
Texas Diabetes & Endocrinology, P.A.	Austin	Texas
Thyroid, Endocrinology, and Diabetes	Dallas	Texas
Velocity Clinical Research, Dallas	Dallas	Texas
Cedar Health Research	Dallas	Texas
Juno Research	Houston	Texas
Consano Clinical Research, LLC	Shavano Park	Texas
Soma Clinical Trials	Wylie	Texas

+ 98 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05869903 on ClinicalTrials.gov ↗ ← All trials in China