Clinical trial NCT06047548: A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3b
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
timeFrame: Week 112
Secondary outcomes:
measure: Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
timeFrame: Week 112
measure: Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
timeFrame: Week 112
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline (Week 0), Week 112
measure: Change from Randomization in Body Weight
timeFrame: Week 60, Week 112
measure: Percent Change from Randomization in Body Weight
timeFrame: Week 60, Week 112
measure: Change from Randomization in Waist Circumference
timeFrame: Week 60, Week 112
measure: Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period
timeFrame: Week 84
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research - Pelham
state: Alabama
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Hammond
country: United States
facility: Asha Clinical Research - Munster
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Fayette
country: United States
facility: Prime Health and Wellness/SKYCRNG
state: Mississippi
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: