NCT07794579From ClinicalTrials.govRecruiting

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

Overweight
Prediabetic State
Prehypertension
Obesity, Abdominal

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Eli Lilly and Company
Enrolment target: 2,001
Started: 26 August 2026
Main results due: August 2029
Study sites: 180
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(180)

Pinnacle Research Group, LLC
Anniston, Alabama, United States
Recruiting
Central Research Associates
Birmingham, Alabama, United States
Recruiting
Cahaba Research - Pelham
Pelham, Alabama, United States
Recruiting
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, United States
Recruiting
Absolute Clinical Research
Phoenix, Arizona, United States
Not yet recruiting
Synexus Clinical Research US, Inc./Orange Grove Family Practice
Tucson, Arizona, United States
Recruiting
Orange County Research Center
Lake Forest, California, United States
Recruiting
Healthy Brain Clinic
Long Beach, California, United States
Recruiting
Los Angeles Institute for Metabolic Research
Los Angeles, California, United States
Recruiting
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Recruiting
Artemis Institute for Clinical Research
Riverside, California, United States
Recruiting
Riverside Clinical
Riverside, California, United States
Recruiting
Headlands Research- Sacramento
Sacramento, California, United States
Recruiting
Norcal Endocrinology & Internal Medicine
San Ramon, California, United States
Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Not yet recruiting
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Recruiting
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Recruiting
Flourish Research Acquisition, LLC dba Flourish Research - North Miami
Miami, Florida, United States
Recruiting
New Age Medical Research Corporation
Miami, Florida, United States
Recruiting
Renstar Medical Research
Ocala, Florida, United States
Not yet recruiting
Headlands Research Orlando
Orlando, Florida, United States
Not yet recruiting
Oviedo Medical Research
Oviedo, Florida, United States
Not yet recruiting
Care Access - St. Petersburg
St. Petersburg, Florida, United States
Recruiting
Precision Clinical Research
Sunrise, Florida, United States
Recruiting
SKY Clinical Research Network Group-Brown
Atlanta, Georgia, United States
Recruiting
HOPE Clinical Research & Wellness
Conyers, Georgia, United States
Recruiting
Care Access - Dalton Walmart
Dalton, Georgia, United States
Recruiting
Care Access - Decatur
Decatur, Georgia, United States
Recruiting
Family First Medical Center
Idaho Falls, Idaho, United States
Not yet recruiting
Solaris Clinical Research
Meridian, Idaho, United States
Recruiting
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Recruiting
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Recruiting
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Not yet recruiting
Monroe Biomedical Research - Louisville
Louisville, Kentucky, United States
Not yet recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Not yet recruiting
IMA Clinical Research Monroe-Main
Monroe, Louisiana, United States
Recruiting
Centennial Medical Group
Columbia, Maryland, United States
Not yet recruiting
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, United States
Not yet recruiting
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Recruiting
Great Lakes Research Institute
Southfield, Michigan, United States
Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Not yet recruiting
Headlands Research-Twin Cities
Maplewood, Minnesota, United States
Recruiting
Clinvest Headlands Llc
Springfield, Missouri, United States
Recruiting
M3 Wake Research - Las Vegas Cimarron
Las Vegas, Nevada, United States
Recruiting
Renascor Clinical Research
Reno, Nevada, United States
Not yet recruiting
IMA Clinical Research Warren
Warren Township, New Jersey, United States
Recruiting
Drug Trials America
Hartsdale, New York, United States
Recruiting
NYC Research INC
Long Island City, New York, United States
Not yet recruiting
Rochester Clinical Research, LLC
Rochester, New York, United States
Recruiting
Medication Management
Greensboro, North Carolina, United States
Recruiting
Monroe Biomedical Research
Monroe, North Carolina, United States
Not yet recruiting
West Clinical Research
Morehead City, North Carolina, United States
Recruiting
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, United States
Recruiting
Lillestol Research
Fargo, North Dakota, United States
Recruiting
Remington-Davis, Inc
Columbus, Ohio, United States
Recruiting
Central States Research
Tulsa, Oklahoma, United States
Recruiting
The Corvallis Clinic, P.C.
Corvallis, Oregon, United States
Not yet recruiting
Clinical Renal Associates Ltd.
Media, Pennsylvania, United States
Recruiting
Suburban Research Associates
West Chester, Pennsylvania, United States
Recruiting

Showing 60 of 180 sites — filter to narrow it down. 61 of the 180 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07794579. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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