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

June 2, 2026 updated by: Eli Lilly and Company

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

The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Puerto Rico Medical Research
      • Vega Baja, Puerto Rico, 00694
        • Wellness clinical Research Vega Baja
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Cahaba Research
      • Pelham, Alabama, United States, 35124
        • Cahaba Research - Pelham
    • California
      • Santa Ana, California, United States, 92701
        • Southern California Dermatology, Inc.
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
    • Georgia
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • Prime Health and Wellness/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Sunset
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance For multispecialty Research, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-Clinsearch, LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide [Zepbound] versus injectable semaglutide [Wegovy]) 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: Orforglipron
Participants will receive orforglipron orally
Drug: Orforglipron
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 52
Baseline, Week 52
Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment
Time Frame: Week 52
Week 52
Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5
Time Frame: Week 52
Week 52
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2024

Primary Completion (Actual)

November 21, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27239
  • J2A-MC-GZPN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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