A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
- Conditions
- ObesityOverweight
- Interventions
- Drug: Placebo
- Registration Number
- NCT06584916
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.
- Detailed Description
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Have completed the SURMOUNT-5 study on study treatment
- Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
- Have a prior or planned surgical treatment for obesity
- Have acute or chronic hepatitis
- Have a history of acute or chronic pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Orforglipron Participants will receive orforglipron orally Placebo Placebo Participants will receive placebo orally
- Primary Outcome Measures
Name Time Method Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 Week 52
- Secondary Outcome Measures
Name Time Method Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment Week 52 Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5 Week 52 Change from Baseline in Body Weight Baseline, Week 52 Change from Baseline in Waist Circumference Baseline, Week 52 Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 Week 24
Related Research Topics
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Trial Locations
- Locations (29)
Cahaba Research
🇺🇸Birmingham, Alabama, United States
Cahaba Research - Pelham
🇺🇸Pelham, Alabama, United States
Southern California Dermatology, Inc.
🇺🇸Santa Ana, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
Prime Health and Wellness/SKYCRNG
🇺🇸Fayette, Mississippi, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Palm Research Center Sunset
🇺🇸Las Vegas, Nevada, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
WR-Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Bellaire, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Puerto Rico Medical Research
🇵🇷Ponce, Puerto Rico
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Wellness clinical Research Vega Baja
🇵🇷Vega Baja, Puerto Rico