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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06584916

Enrollment

376

Registered

2024-09-05

Start date

2024-09-13

Completion date

2025-11-21

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Maintenance, Weight maintenance, Body weight changes, Weight loss, Incretins, Hormones, Hormone substitutes, Hormone antagonists, Physiological effects of drugs, tirzepatide, semaglutide, Zepbound, Wegovy, injectable GLP-1, oral GLP-1, incretin therapy, GLP-1 receptor agonist, crossover from injectable

Brief summary

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).

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.

Interventions

DRUGOrforglipron

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Phase 3b

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5	Week 52

Secondary

Measure	Time frame
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

Countries

Puerto Rico, United States

Contacts

STUDY_DIRECTORCall 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026