Recruiting
Phase 3

Orforglipron

Sponsor:

Eli Lilly and Company

Code:

NCT07794579

Conditions

Overweight

Prediabetic State

Prehypertension

Obesity, Abdominal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Orforglipron

Placebo

Study Details

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.

Conditions

Overweight

Prediabetic State

Prehypertension

Obesity, Abdominal

Study ID

NCT07794579

Start date

Aug 26, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2001 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orforglipron

Participants will receive orforglipron orally

experimental: Orforglipron to Placebo

Participants will receive orforglipron orally followed by placebo orally

experimental: Placebo to Orforglipron

Participants will receive placebo orally followed by orforglipron orally

Interventions

Orforglipron

Administered orally

Placebo

Administered orally

Primary outcome measure

  • Time to Onset of Obesity Related Complications or Class 1 Obesity [ Time Frame: Baseline to Week 104 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Pinnacle Research Group, LLC

Recruiting

Anniston, Alabama, United States, 36207

Contacts

256-236-0055

Principal Investigator:

Almena Free

Central Research Associates

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

205-327-1077

Principal Investigator:

David DeAtkine

Cahaba Research - Pelham

Recruiting

Pelham, Alabama, United States, 35124

Contacts

205-408-4134

Principal Investigator:

David Wever

Care Access - 801 South Power Road, Mesa

Recruiting

Mesa, Arizona, United States, 85206

Contacts

877-791-0656

Principal Investigator:

Michael Waters

Synexus Clinical Research US, Inc./Orange Grove Family Practice

Recruiting

Tucson, Arizona, United States, 85741

Contacts

520-333-4515

Principal Investigator:

Kevin Pounds

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Contacts

714-550-9990

Principal Investigator:

JOEL NEUTEL

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Contacts

562-606-5999

Principal Investigator:

Dung Trinh

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

Contacts

213-373-8380

Principal Investigator:

Juan Frias

Desert Oasis Healthcare Medical Group

Recruiting

Palm Springs, California, United States, 92262

Contacts

760-320-9505

Principal Investigator:

Michael Jardula

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Contacts

951-374-1190

Principal Investigator:

Jack Vu

Riverside Clinical

Recruiting

Riverside, California, United States, 92506

Contacts

951-374-8000

Principal Investigator:

Cydney Osano

Headlands Research- Sacramento

Recruiting

Sacramento, California, United States, 95821

Contacts

916-434-8230

Principal Investigator:

Jeffrey Wayne

Norcal Endocrinology & Internal Medicine

Recruiting

San Ramon, California, United States, 94583

Contacts

925-552-5280

Principal Investigator:

Yshay Shlesinger

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Contacts

925-930-7267

Principal Investigator:

Helen Stacey

Chase Medical Research, LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

203-419-4420

Principal Investigator:

Joseph Soufer

Excel Medical Clinical Trials

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

305-631-6704

Principal Investigator:

Michael Hafran

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Recruiting

Miami, Florida, United States, 33138

Contacts

786-772-0411

Principal Investigator:

Rimsky Denis

New Age Medical Research Corporation

Recruiting

Miami, Florida, United States, 33186

Contacts

305-596-9901

Principal Investigator:

Victoria Bedell

Care Access - St. Petersburg

Recruiting

St. Petersburg, Florida, United States, 33710

Contacts

877-791-0656

Principal Investigator:

Gigi Lefebvre

Precision Clinical Research

Recruiting

Sunrise, Florida, United States, 33351

Principal Investigator:

Jeffrey Schneider

SKY Clinical Research Network Group-Brown

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

888-659-4363

Principal Investigator:

Tamara Brown

HOPE Clinical Research & Wellness

Recruiting

Conyers, Georgia, United States, 30094

Contacts

770-679-5591

Principal Investigator:

Alvin Griffin

Care Access - Dalton Walmart

Recruiting

Dalton, Georgia, United States, 30720

Contacts

877-791-0656

Principal Investigator:

Chukwukanene Ofiaeli

Care Access - Decatur

Recruiting

Decatur, Georgia, United States, 30030

Contacts

678-470-4394

Principal Investigator:

Marie Walton

Solaris Clinical Research

Recruiting

Meridian, Idaho, United States, 83646

Contacts

208-288-0123

Principal Investigator:

David Butuk

Great Lakes Clinical Trials - Ravenswood

Recruiting

Chicago, Illinois, United States, 60640

Contacts

773-275-3500 Ext 162

Principal Investigator:

Rupal Trivedi

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

515-329-6800

Principal Investigator:

Anuj Bhargava

IMA Clinical Research Monroe-Main

Recruiting

Monroe, Louisiana, United States, 71201

Contacts

318-737-1098

Principal Investigator:

Mark Napoli

Great Lakes Research Group, Inc.

Recruiting

Bay City, Michigan, United States, 48706

Contacts

989-895-9100

Principal Investigator:

Jeffrey Potts

Great Lakes Research Institute

Recruiting

Southfield, Michigan, United States, 48075

Principal Investigator:

David Strong

Headlands Research-Twin Cities

Recruiting

Maplewood, Minnesota, United States, 55109

Principal Investigator:

Charlene McEvoy

Clinvest Headlands Llc

Recruiting

Springfield, Missouri, United States, 65807

Contacts

417-883-7889

Principal Investigator:

Cory Bethmann

M3 Wake Research - Las Vegas Cimarron

Recruiting

Las Vegas, Nevada, United States, 89113

Contacts

702-893-8968

Principal Investigator:

Dana Trippi

IMA Clinical Research Warren

Recruiting

Warren Township, New Jersey, United States, 07059

Principal Investigator:

Nancy Phillips

Drug Trials America

Recruiting

Hartsdale, New York, United States, 10530

Contacts

914-341-2346

Principal Investigator:

Michael Gerdis

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Contacts

585-288-0890

Principal Investigator:

Patrick Connors

Medication Management

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

336-763-6968

Principal Investigator:

James Franklin

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

252-515-0050

Principal Investigator:

Patrick Morgante

Trial Management Associates - Wilmington - Floral Parkway

Recruiting

Wilmington, North Carolina, United States, 28403

Principal Investigator:

William Jones

Lillestol Research

Recruiting

Fargo, North Dakota, United States, 58104

Contacts

701-232-7705

Principal Investigator:

Michael Lillestol

Remington-Davis, Inc

Recruiting

Columbus, Ohio, United States, 43215

Contacts

614-487-2560

Principal Investigator:

Roy St. John

Central States Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

918-645-5400

Principal Investigator:

Sarah Land

Clinical Renal Associates Ltd.

Recruiting

Media, Pennsylvania, United States, 19063

Contacts

610-872-8501

Principal Investigator:

Heather Mascio

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Principal Investigator:

Omer Abdullah

Care Access - Mauldin

Recruiting

Mauldin, South Carolina, United States, 29662

Contacts

864-202-6290

Principal Investigator:

Anne Tuggle

New Phase Research and Development

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

865-200-8364

Principal Investigator:

Amanda Miller

Clinical Research Associates Inc

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

615-329-0197

Principal Investigator:

Stephan Sharp

IMA Clinical Research Austin

Recruiting

Austin, Texas, United States, 78745

Principal Investigator:

Yu-Mei Liu

Headlands Horizons, LLC dba Headlands Research-Brownsville

Recruiting

Brownsville, Texas, United States, 78526

Principal Investigator:

Christopher Romero

Cedar Health Research - Texas Native Health

Recruiting

Dallas, Texas, United States, 75235

Contacts

214-253-8170

Principal Investigator:

Debbie Bridges

Headlands Research-El Paso

Recruiting

El Paso, Texas, United States, 79902

Contacts

915-910-7088

Principal Investigator:

Ryan Casey

Cedar Health Research - Euless

Recruiting

Euless, Texas, United States, 76040

Contacts

214-253-8170

Principal Investigator:

Sefanit Gebretsadik

Care Access - Houston - Clinical Trials Center by Walmart & Care Access

Recruiting

Houston, Texas, United States, 77082

Contacts

877-791-0656

Principal Investigator:

Ali Bajwa

DCOL Center for Clinical Research

Recruiting

Longview, Texas, United States, 75605

Contacts

903-238-8854

Principal Investigator:

Kathleen Harris

IMA Clinical Research San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-692-7157

Principal Investigator:

Lisa Blair

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

210-545-4900

Principal Investigator:

Michelle Welch

Care Access - Tyler - Clinical Trials Center by Walmart & Care Access

Recruiting

Tyler, Texas, United States, 75704

Contacts

877-791-0656

Principal Investigator:

Alphonse Ekole

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

Contacts

804-477-3045

Principal Investigator:

Robert Call

Frontier Clinical Research, LLC

Recruiting

Kingwood, West Virginia, United States, 26537

Contacts

304-441-2006

Principal Investigator:

Jeffry Pilney

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Predyslipidemia
  • Weight management
  • Cardiovascular risk factors
  • Obesity prevention
  • Lower BMI
  • Early intervention in people with obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.