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Clinical Trials in India / NCT05869903
Active, not recruiting Phase 3

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

NCT05869903 · tracked via the Priya Life Science India 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)

Orforglipron →Placebo

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
No
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)

FacilityCityRegionStatus
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.

More Eli Lilly and Company trials in India

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes) Active, not recruiting
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis Recruiting
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) Recruiting
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes Recruiting
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer Active, not recruiting

Other trials for the same condition

SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity Active, not recruiting
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting
Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery Recruiting
A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes Recruiting
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 India