A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity | NCT07794579 | Trialant
Not yet recruitingInterventionalPhase 3Updated Aug 31, 2026
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
ClinicalTrials.gov ID
NCT07794579
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Overall Status
Not yet recruiting
Study Type
Interventional
Phase
Phase 3
Enrollment
2,001Estimated
Last Update Posted
Aug 31, 2026Actual
Start Date
Sep 2026Estimated
Primary Completion Date
Aug 2029Estimated
Completion Date
Sep 2030Estimated
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Brief Summary
This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.
Overweight
Prediabetic State
Prehypertension
Obesity, Abdominal
Orforglipron
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have an increased waist-to-height ratio of ≥0.5
Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)
Have at least one unsuccessful attempt to reduce body weight based on diet and exercise
Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds
Exclusion Criteria:
Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
Do not have a stable body weight within 90 days before screening
Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)
Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening
Have a prior or planned surgical treatment or procedure for obesity
Have hypertension or history of hypertension
Have dyslipidemia or history of dyslipidemia
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orContact
LillyTrials@Lilly.com317-615-4559
Physicians interested in becoming principal investigators please contactContact
clinical_inquiry_hub@lilly.com
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Pinnacle Research Group, LLC
Anniston, Alabama 36207, United States
-Contact
2562360055
Almena FreePrincipal Investigator
Central Research Associates
Birmingham, Alabama 35205, United States
Cahaba Research - Pelham
Pelham, Alabama 35124, United States
Care Access - 801 South Power Road, Mesa
Mesa, Arizona 85206, United States
Absolute Clinical Research
Phoenix, Arizona 85051, United States
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona 85741, United States
Orange County Research Center
Lake Forest, California 92630, United States
Healthy Brain Clinic
Long Beach, California 90804, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California 90015, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California 92262, United States
Artemis Institute for Clinical Research
Riverside, California 92503, United States
Riverside Clinical
Riverside, California 92506, United States
Headlands Research- Sacramento
Sacramento, California 95821, United States
Norcal Endocrinology & Internal Medicine
San Ramon, California 94583, United States
Diablo Clinical Research, Inc.
Walnut Creek, California 94598, United States
Yale University School of Medicine
New Haven, Connecticut 06519, United States
Chase Medical Research, LLC
Waterbury, Connecticut 06708, United States
Excel Medical Clinical Trials
Boca Raton, Florida 33434, United States
Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida 33138, United States
New Age Medical Research Corporation
Miami, Florida 33186, United States
Renstar Medical Research
Ocala, Florida 34471, United States
Headlands Research Orlando
Orlando, Florida 32803, United States
Oviedo Medical Research
Oviedo, Florida 32765, United States
Care Access - St. Petersburg
St. Petersburg, Florida 33710, United States
Precision Clinical Research
Sunrise, Florida 33351, United States
SKY Clinical Research Network Group-Brown
Atlanta, Georgia 30331, United States
HOPE Clinical Research & Wellness
Conyers, Georgia 30094, United States
Care Access - Dalton Walmart
Dalton, Georgia 30720, United States
Care Access - Decatur
Decatur, Georgia 30030, United States
Family First Medical Center
Idaho Falls, Idaho 83404, United States
Solaris Clinical Research
Meridian, Idaho 83646, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606, United States
Monroe Biomedical Research - Louisville
Louisville, Kentucky 40213, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808, United States
IMA Clinical Research Monroe-Main
Monroe, Louisiana 71201, United States
Centennial Medical Group
Columbia, Maryland 21045, United States
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts 02115, United States
Great Lakes Research Group, Inc.
Bay City, Michigan 48706, United States
Great Lakes Research Institute
Southfield, Michigan 48075, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098, United States
Headlands Research-Twin Cities
Maplewood, Minnesota 55109, United States
Clinvest Headlands Llc
Springfield, Missouri 65807, United States
M3 Wake Research - Las Vegas Cimarron
Las Vegas, Nevada 89113, United States
Renascor Clinical Research
Reno, Nevada 89509, United States
IMA Clinical Research Warren
Warren Township, New Jersey 07059, United States
Drug Trials America
Hartsdale, New York 10530, United States
NYC Research INC
Long Island City, New York 11106, United States
Rochester Clinical Research, LLC
Rochester, New York 14609, United States
Medication Management
Greensboro, North Carolina 27405, United States
West Clinical Research
Morehead City, North Carolina 28557, United States