← Trials/Trial dossier/NCT06584916

CompletedPhase 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)

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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

29

Recruiting sites

Enrollment

376

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06584916
Org study ID27239
Secondary IDJ2A-MC-GZPNEli Lilly and Company

Timeline

Milestones

Study first posted2024-09-05actual
Study start2024-09-13actual
Primary completion2025-11-21actual
Study completion2025-11-21actual
Last update posted2025-12-22actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

6 endpoints
Primary/protocol endpoint

Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

Time frame:Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

Time frame:Week 24

Body weight, % change

percent change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.