A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

Phase 3RecruitingNCT06972459

Eli Lilly and Company600 enrolled

Overview

The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Obesity Overweight

Interventions

OrforglipronDRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * Have a history of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Have type 1 diabetes, type 2 diabetes, or any other types of diabetes * Have an unstable body weight within 90 days prior to screening * Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening * Have acute or chronic hepatitis or pancreatitis * Are taking other medications or alternative remedies to manage weight loss

Locations (80)

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 72