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

NCT ID: NCT06584916

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2025-11-21

Brief Summary

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The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.

Detailed Description

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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.

Conditions

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Obesity Overweight

Keywords

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Maintenance Weight maintenance Body weight changes Weight loss Incretins Hormones Hormone substitutes Hormone antagonists Physiological effects of drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 3b
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Orforglipron

Participants will receive orforglipron orally

Group Type EXPERIMENTAL

Orforglipron

Intervention Type DRUG

Administered orally

Placebo

Participants will receive placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Orforglipron

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Cahaba Research

Birmingham, Alabama, United States

Site Status

Cahaba Research - Pelham

Pelham, Alabama, United States

Site Status

Southern California Dermatology, Inc.

Santa Ana, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

University Clinical Investigators, Inc.

Tustin, California, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status

Prime Health and Wellness/SKYCRNG

Fayette, Mississippi, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

Palm Research Center Sunset

Las Vegas, Nevada, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, United States

Site Status

Lillestol Research

Fargo, North Dakota, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status

WR-Clinsearch, LLC

Chattanooga, Tennessee, United States

Site Status

The University of Texas Health Science Center at Houston

Bellaire, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

North Texas Endocrine Center

Dallas, Texas, United States

Site Status

Biopharma Informatic, LLC

Houston, Texas, United States

Site Status

PlanIt Research, PLLC

Houston, Texas, United States

Site Status

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status

Puerto Rico Medical Research

Ponce, , Puerto Rico

Site Status

Wellness clinical Research Vega Baja

Vega Baja, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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27239

Identifier Type: -

Identifier Source: org_study_id

J2A-MC-GZPN

Identifier Type: OTHER

Identifier Source: secondary_id