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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT06584916 (opens ClinicalTrials.gov in a new tab)Other id27239Other idJ2A-MC-GZPN
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
376 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Puerto Rico

Start
13 Sept 2024
Primary completion
21 Nov 2025
Completion
21 Nov 2025
First posted
5 Sept 2024
Last update posted
4 Jun 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    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

    13 Sept 2024 to 21 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms2

  • Experimental

    Orforglipron

    Participants will receive orforglipron orally

  • Placebo comparator

    Placebo

    Participants will receive placebo orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

    Time frame · Week 52

Secondary outcomes(5)

  1. Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment

    Time frame · Week 52

  2. Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5

    Time frame · Week 52

  3. Change from Baseline in Body Weight

    Time frame · Baseline, Week 52

  4. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 52

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

    Time frame · Week 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

4 results

Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial.

Aronne et al. 2026Nature medicinecited by 14

PMID 42120723PMC13375559DOI 10.1038/s41591-026-04386-7PUB-42120723

CC BY4 results
Download PDFSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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