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

Obesity Clinical Trial

Official title:

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06047548
• Other study ID #: 18720
• Secondary ID: I8F-MC-GPIQ
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 20, 2023
• Est. completion date: May 22, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: May 22, 2026
• Est. primary completion date: May 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	WR-Clinsearch, LLC	Chattanooga	Tennessee
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	SKY Clinical Research Network Group - Hall	Fayette	Mississippi
United States	Asha Clinical Research - Munster	Hammond	Indiana
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	National Research Institute - Wilshire	Los Angeles	California
United States	L-MARC Research Center	Louisville	Kentucky
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	New Horizon Research Center	Miami	Florida
United States	Intend Research, LLC	Norman	Oklahoma
United States	Oviedo Medical Research	Oviedo	Florida
United States	Cahaba Research - Pelham	Pelham	Alabama
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Encompass Clinical Research	Spring Valley	California
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 112
Secondary	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.	Week 112
Secondary	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.	Week 112
Secondary	Percent Change from Baseline in Body Weight		Baseline (Week 0), Week 112
Secondary	Change from Randomization in Body Weight		Week 60, Week 112
Secondary	Percent Change from Randomization in Body Weight		Week 60, Week 112
Secondary	Change from Randomization in Waist Circumference		Week 60, Week 112
Secondary	Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period		Week 84

External Links

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