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

Eli Lilly and Company376 enrolled

Overview

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

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

376

Conditions

Obesity Overweight

Interventions

OrforglipronDRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have completed the SURMOUNT-5 study 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

Locations (29)

Outcomes

Primary Outcomes

Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

Time frame: Week 52

Secondary Outcomes

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

Time frame: Week 52

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

Time frame: Week 52

Change from Baseline in Body Weight

Time frame: Baseline, Week 52

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 52

Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

Time frame: Week 24

Data from ClinicalTrials.gov

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