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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05822830
Recruitment Status : Active, not recruiting
First Posted : April 21, 2023
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Tirzepatide Drug: Semaglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 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 in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
Actual Study Start Date : April 21, 2023
Estimated Primary Completion Date : November 6, 2024
Estimated Study Completion Date : November 6, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC).
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Active Comparator: Semaglutide
Participants will receive semaglutide SC.
 Drug: Semaglutide
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]

Secondary Outcome Measures :
  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
  3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
  4. Percentage of Participants Who Achieve ≥25% Body Weight Reduction [ Time Frame: Week 72 ]
  5. Change from Baseline in Waist Circumference in Centimeter (cm) [ Time Frame: Baseline, Week 72 ]
  6. Percentage of Participants Who Achieve ≥30% Body Weight Reduction [ Time Frame: Week 72 ]
  7. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
  8. Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg [ Time Frame: Baseline, Week 72 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05822830


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05822830    
Other Study ID Numbers: 17203
I8F-MC-GPHJ ( Other Identifier: Eli Lilly and Company )
U1111-1283-5404 ( Other Identifier: UTN Number )
First Posted: April 21, 2023    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org

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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:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Tirzepatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists