A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Phase 3Active Not RecruitingNCT06047548

Eli Lilly and Company400 enrolled

Overview

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

All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Overweight Obesity

Interventions

TirzepatideDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW) Exclusion Criteria: * Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma. * Have a self-reported change in BW\>5 kilogram (kg) within 3 months prior to screening * Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening. * Have a history of chronic or acute pancreatitis * Have any of the following cardiovascular conditions within 3 months prior to week 0. * Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF) * family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt

Locations (20)

Cahaba Research - Pelham

Pelham, Alabama, United States

Outcomes

Primary Outcomes

Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period

Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau.

Time frame: Week 112

Secondary Outcomes

Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period

Assessment of (yes/no) of maintaining ≥80% of the BW reduction achieved during the 60-week weight loss period will be measured in participants who have reached a BW plateau.

Time frame: Week 112

Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization

Assessment of (yes/no) of maintaining ≥15% BW reduction for participants who have already lost ≥15% BW at randomization will be measured in participants who have reached a BW plateau.

Time frame: Week 112

Percent Change from Baseline in Body Weight

Time frame: Baseline (Week 0), Week 112

Change from Randomization in Body Weight

Time frame: Week 60, Week 112

Percent Change from Randomization in Body Weight

Time frame: Week 60, Week 112

Change from Randomization in Waist Circumference

Time frame: Week 60, Week 112

Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period

Data from ClinicalTrials.gov

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