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ObesityPhase 3SURMOUNT-5NCT05822830

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

A Phase 3 study testing Tirzepatide and Semaglutide in people with Obesity and Overweight, run by Eli Lilly and Company at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Tirzepatide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
751 participants
Where
32 sitesin 2 countries
Study dates
21 Apr 2023to 13 Nov 2024
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

United States30 sites

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • Cahaba Research

    Birmingham, Alabama, 35242

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Prime Health and Wellness/SKYCRNG

    Fayette, Mississippi, 39069

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • New Horizon Research Center

    Miami, Florida, 33165

  • Weill Cornell Medical College

    New York, New York, 10021

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • Cahaba Research - Pelham

    Pelham, Alabama, 35124

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Southern California Dermatology, Inc.

    Santa Ana, California, 92701

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Puerto Rico2 sites

  • Puerto Rico Medical Research

    Ponce, 00717

  • Wellness clinical Research Vega Baja

    Vega Baja, 00694

Other trials in Puerto Rico

About this study

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

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.

Conditions
Obesity, Overweight
Keywords
Metabolism and Nutrition, Disorder, Prediabetes, Diet, Exercise
Medical subject headings
Obesity, Overweight, Disease, Prediabetic State, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05822830
Study groupRoleWhat they receive
15 mg or MTD - TirzepatideExperimentalParticipants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose [MTD (10 mg or 15 mg)] until Week 72.
Receives: Drug: Tirzepatide
2.4 mg or MTD - SemaglutideActive comparatorParticipants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight

    Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.

    Measured: Baseline, Week 72

Secondary outcomes (8)

  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.

    Measured: Week 72

  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.

    Measured: Week 72

  3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction

    Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.

    Measured: Week 72

  4. Percentage of Participants Who Achieve ≥25% Body Weight Reduction

    Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.

    Measured: Week 72

  5. Change From Baseline in Waist Circumference in Centimeter

    Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.

    Measured: Baseline, Week 72

  6. Percentage of Participants Who Achieve ≥30% Body Weight Reduction

    Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.

    Measured: Week 72

  7. Change From Baseline in Body Mass Index (BMI)

    Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment*Time(Type III sum of squares) as variables.

    Measured: Baseline, Week 72

  8. Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide

    Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

    Measured: Baseline, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start21 Apr 2023
  3. Primary completion13 Nov 2024
  4. Study completion13 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 3b
Masking
None (open label)
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822830
Sponsor's protocol ID
17203
Other IDs
I8F-MC-GPHJ, U1111-1283-5404
Acronym
SURMOUNT-5
Status last verified
Nov 2025
First submitted
16 Sep 2022
Last updated
26 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

Publications

  • Kitamoto T, Yoshino M, Shingaki T, Oura T, Gomez Valderas E, Dunn JP. Tirzepatide compared with semaglutide in obesity disease: a subpopulation analysis applying Japan Society for the Study of Obesity criteria in the global SURMOUNT-5 trial. Curr Med Res Opin. 2026 Jul 11:1-13. doi: 10.1080/03007995.2026.2695047. Online ahead of print.

    PubMed 42434924

  • Aronne LJ, Horn DB, Kokkinos AD, Falcon BL, Wang H, Hoffmann HT, Lee CJ, Dunn JP. Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis. Am J Med. 2026 Jul;139(7):913-921. doi: 10.1016/j.amjmed.2026.03.010. Epub 2026 Mar 20.

    PubMed 41865857

  • Mamas MA, Bays H, Li R, Upadhyay N, Irani T, Senyucel C, Dunn JP, Liu-Seifert H. Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: post-hoc analysis of the SURMOUNT-5 trial. Eur Heart J Open. 2025 Sep 2;5(5):oeaf117. doi: 10.1093/ehjopen/oeaf117. eCollection 2025 Sep.

    PubMed 40980721

  • Aronne LJ, Horn DB, le Roux CW, Ho W, Falcon BL, Gomez Valderas E, Das S, Lee CJ, Glass LC, Senyucel C, Dunn JP; SURMOUNT-5 Trial Investigators. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. N Engl J Med. 2025 Jul 3;393(1):26-36. doi: 10.1056/NEJMoa2416394. Epub 2025 May 11.

    PubMed 40353578

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