Clinical trial NCT06584916: A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Keywords: Maintenance
Weight maintenance
Body weight changes
Weight loss
Incretins
Hormones
Hormone substitutes
Hormone antagonists
Physiological effects of drugs
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3b
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
timeFrame: Week 52
Secondary outcomes:
measure: Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment
timeFrame: Week 52
measure: Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5
timeFrame: Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 52
measure: Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Pelham
country: United States
facility: Cahaba Research - Pelham
state: Alabama
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Fayette
country: United States
facility: Prime Health and Wellness/SKYCRNG
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research
city: Vega Baja
country: Puerto Rico
facility: Wellness clinical Research Vega Baja
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: