A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

Phase 3

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Orforglipron; 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.

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Study Start: 2024-09-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Have completed the SURMOUNT-5 study on study treatment

Exclusion Criteria

• 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

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

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