A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Obesity Clinical Trial

— SURMOUNT-5  

Official title:

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05822830
• Other study ID #: 17203
• Secondary ID: I8F-MC-GPHJU1111
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 21, 2023
• Est. completion date: November 6, 2024

Study information

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

Clinical Trial Summary

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: November 6, 2024
• Est. primary completion date: November 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a body mass index (BMI) of =30 kilogram per square meter (kg/m²) or =27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
• Have a history of at least 1 unsuccessful dietary effort to lose body weight

Exclusion Criteria:

• Diabetes mellitus
• Change in body weight greater than 5 kg within 3 months prior to starting study
• Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
• History of pancreatitis
• 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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC
• Semaglutide
Administered SC

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Medical Research	Ponce
Puerto Rico	Wellness clinical Research Vega Baja	Vega Baja
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Cahaba Research	Birmingham	Alabama
United States	WR-Clinsearch, LLC	Chattanooga	Tennessee
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Lillestol Research	Fargo	North Dakota
United States	SKY Clinical Research Network Group - Hall	Fayette	Mississippi
United States	PharmQuest	Greensboro	North Carolina
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
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	Weill Cornell Medical College	New York	New York
United States	Intend Research, LLC	Norman	Oklahoma
United States	Cahaba Research - Pelham	Pelham	Alabama
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Encompass Clinical Research	Spring Valley	California
United States	ForCare Clinical Research	Tampa	Florida
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	University Clinical Investigators, Inc.	Tustin	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

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 72
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Week 72
Secondary	Percentage of Participants Who Achieve =15% Body Weight Reduction		Week 72
Secondary	Percentage of Participants Who Achieve =20% Body Weight Reduction		Week 72
Secondary	Percentage of Participants Who Achieve =25% Body Weight Reduction		Week 72
Secondary	Change from Baseline in Waist Circumference in Centimeter (cm)		Baseline, Week 72
Secondary	Percentage of Participants Who Achieve =30% Body Weight Reduction		Week 72
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 72
Secondary	Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg		Baseline, Week 72

External Links

•   A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)