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

Phase 3

Active, not recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: Placebo; Drug: Tirzepatide

• Registration Number: NCT06047548
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study Start: 2023-09-20
• Study First Posted: 2023-09-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo.
Tirzepatide 5 milligram (mg)	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC).
Tirzepatide Maximum Tolerated Dose	Tirzepatide	Participants will receive tirzepatide SC.

Primary Outcome Measures

Name	Time	Method
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period	Week 112	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline (Week 0), Week 112
Change from Randomization in Body Weight	Week 60, Week 112
Percent Change from Randomization in Body Weight	Week 60, Week 112
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period	Week 84
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period	Week 112	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.
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization	Week 112	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.
Change from Randomization in Waist Circumference	Week 60, Week 112

Trial Locations

Locations (20)

New Horizon Research Center; 🇺🇸 Miami, Florida, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

Southern California Dermatology, Inc.; 🇺🇸 Santa Ana, California, United States

Velocity Clinical Research, Westlake; 🇺🇸 Los Angeles, California, United States

Asha Clinical Research - Munster; 🇺🇸 Hammond, Indiana, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

Prime Health and Wellness/SKYCRNG; 🇺🇸 Fayette, Mississippi, United States

Velocity Clinical Research, Dallas; 🇺🇸 Dallas, Texas, United States

Southern Endocrinology Associates; 🇺🇸 Mesquite, Texas, United States

Cahaba Research - Pelham; 🇺🇸 Pelham, Alabama, United States

Oviedo Medical Research; 🇺🇸 Oviedo, Florida, United States

Rocky Mountain Clinical Research; 🇺🇸 Idaho Falls, Idaho, United States

WR-Clinsearch, LLC; 🇺🇸 Chattanooga, Tennessee, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Bellaire, Texas, United States

Consano Clinical Research, LLC; 🇺🇸 Shavano Park, Texas, United States

Rophe Adult and Pediatric Medicine/SKYCRNG; 🇺🇸 Union City, Georgia, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

L-MARC Research Center; 🇺🇸 Louisville, Kentucky, United States