A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Phase 3RecruitingNCT07794579

Eli Lilly and Company2,001 enrolled

Overview

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,001

Conditions

Overweight Prediabetic State Prehypertension Obesity, Abdominal

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have an increased waist-to-height ratio of ≥0.5 * Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia) * Have at least one unsuccessful attempt to reduce body weight based on diet and exercise * Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds Exclusion Criteria: * Have type 1 diabetes, type 2 diabetes, or any other type of diabetes * Do not have a stable body weight within 90 days before screening * Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold) * Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening * Have a prior or planned surgical treatment or procedure for obesity * Have hypertension or history of hypertension * Have dyslipidemia or history of dyslipidemia

Locations (180)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

RECRUITING

Central Research Associates

Birmingham, Alabama, United States

RECRUITING

Cahaba Research - Pelham

Pelham, Alabama, United States

RECRUITING

Care Access - 801 South Power Road, Mesa

Mesa, Arizona, United States

Outcomes

Primary Outcomes

Time to Onset of Obesity Related Complications or Class 1 Obesity

Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold

Time frame: Baseline to Week 104

Secondary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 104

Time to Onset of Waist-to-Height Ratio ≥0.6

Time frame: Baseline to Week 104

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 104

Time to Onset of Class 1 Obesity

Time frame: Baseline to Week 104

Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia

Time frame: Baseline to Week 104

Time to Onset of Type 2 Diabetes

Time frame: Baseline to Week 104

Percent Change from Baseline in Total Fat Mass

Time frame: Baseline, Week 104

Change from Baseline in Systolic Blood Pressure

Time frame: Baseline, Week 104

Change from Baseline in Glycated Hemoglobin (HbA1c)

Time frame: Baseline, Week 104

Percent Change from Baseline in Triglycerides

Time frame: Baseline, Week 104

Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score

Time frame: Baseline, Week 104

Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

Time frame: Week 4, 12, 24, 52, and 76

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com