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

NCT06584916 | Completed Phase 3 FDA Drug

• 2 other identifiers: 27239J2A-MC-GZPN
• Study Type: interventional
• Target: 376
• Locations: 2 countries
• Sites: 29

Brief Summary

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

Conditions

Obesity; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

  Week 52

Secondary Outcomes (5)

• 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

Study Arms (2)

Orforglipron

EXPERIMENTAL

Participants will receive orforglipron orally

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally

Drug: Placebo

Interventions

Placebo DRUG

Administered orally

Placebo

Orforglipron DRUG

Administered orally

Orforglipron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed the SURMOUNT-5 study on study treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (29)

Cahaba Research

Birmingham, Alabama, 35242, United States

Location

Cahaba Research - Pelham

Pelham, Alabama, 35124, United States

Location

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

Prime Health and Wellness/SKYCRNG

Fayette, Mississippi, 39069, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Palm Research Center Tenaya

Las Vegas, Nevada, 89128, United States

Location

Palm Research Center Sunset

Las Vegas, Nevada, 89148, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, 27408, United States

Location

Lillestol Research

Fargo, North Dakota, 58104, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

WR-Clinsearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Southern Endocrinology Associates

Mesquite, Texas, 75149, United States

Location

Puerto Rico Medical Research

Ponce, 00717, Puerto Rico

Location

Wellness clinical Research Vega Baja

Vega Baja, 00694, Puerto Rico

Location

MeSH Terms

Conditions

Obesity; Overweight; Body Weight Changes; Weight Loss

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 3b

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: September 13, 2024
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PR (2); US (27)