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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05822830
Collaborator
(none)
700
Enrollment
32
Locations
2
Arms
23.1
Anticipated Duration (Months)
21.9
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide 2.4 milligram (mg) in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 78 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 3bPhase 3b
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide 2.4 mg in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
Actual Study Start Date :
Apr 21, 2023
Anticipated Primary Completion Date :
Feb 24, 2025
Anticipated Study Completion Date :
Mar 24, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC).

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Active Comparator: Semaglutide 2.4 Milligram (mg)

    Participants will receive semaglutide 2.4 mg SC.

    Drug: Semaglutide 2.4 mg
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Body Weight [Baseline, Week 72]

    Secondary Outcome Measures

    1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Week 72]

    2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Week 72]

    3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction [Week 72]

    4. Percentage of Participants Who Achieve ≥25% Body Weight Reduction [Week 72]

    5. Change from Baseline in Waist Circumference in Centimeter (cm) [Baseline, Week 72]

    6. Percentage of Participants Who Achieve ≥30% Body Weight Reduction [Week 72]

    7. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 72]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cahaba Research Birmingham Alabama United States 35242
    2 Cahaba Research - Pelham Pelham Alabama United States 35124
    3 Southern California Dermatology, Inc. Santa Ana California United States 92701
    4 Encompass Clinical Research Spring Valley California United States 91978
    5 University Clinical Investigators, Inc. Tustin California United States 92780
    6 Velocity Clinical Research, Hallandale Beach Hallandale Beach Florida United States 33009
    7 New Horizon Research Center Miami Florida United States 33165
    8 ForCare Clinical Research Tampa Florida United States 33613-1244
    9 Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia United States 30291
    10 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    11 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    12 L-MARC Research Center Louisville Kentucky United States 40213
    13 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
    14 SKY Clinical Research Network Group - Hall Fayette Mississippi United States 39069
    15 StudyMetrix Research Saint Peters Missouri United States 63303
    16 Palm Research Center Tenaya Las Vegas Nevada United States 89128
    17 Palm Research Center Sunset Las Vegas Nevada United States 89148
    18 Weill Cornell Medical College New York New York United States 10021
    19 PharmQuest Life Sciences, LLC Greensboro North Carolina United States 27408
    20 Lillestol Research Fargo North Dakota United States 58104
    21 Alliance for Multispecialty Research, LLC Norman Oklahoma United States 73069
    22 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    23 WR-Clinsearch, LLC Chattanooga Tennessee United States 37397
    24 The University of Texas Health Science Center at Houston Bellaire Texas United States 77401
    25 Velocity Clinical Research, Dallas Dallas Texas United States 75230
    26 North Texas Endocrine Center Dallas Texas United States 75231
    27 Biopharma Informatic, LLC Houston Texas United States 77043
    28 Endocrine Ips, Pllc Houston Texas United States 77079
    29 Southern Endocrinology Associates Mesquite Texas United States 75149
    30 Pinnacle Clinical Research San Antonio Texas United States 78229
    31 Puerto Rico Medical Research Ponce Puerto Rico 00717
    32 Wellness clinical Research Vega Baja Vega Baja Puerto Rico 00694

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05822830
    Other Study ID Numbers:
    • 17203
    • I8F-MC-GPHJ
    • U1111-1283-5404
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Metabolism and Nutrition
    Disorder
    Prediabetes
    Diet
    Exercise
    Additional relevant MeSH terms:
    Obesity
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Apr 27, 2023