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

• ClinicalTrials.gov Identifier: NCT05822830
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2023
• Last Update Posted: March 7, 2024
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: September 16, 2022
• First Posted Date: April 21, 2023
• Last Update Posted Date: March 7, 2024
• Actual Study Start Date: April 21, 2023
• Estimated Primary Completion Date: November 6, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 10, 2023): Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 20, 2023)

• Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥25% Body Weight Reduction [ Time Frame: Week 72 ]
• Change from Baseline in Waist Circumference in Centimeter (cm) [ Time Frame: Baseline, Week 72 ]
• Percentage of Participants Who Achieve ≥30% Body Weight Reduction [ Time Frame: Week 72 ]
• Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
• Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg [ Time Frame: Baseline, Week 72 ]

Original Secondary Outcome Measures (submitted: April 10, 2023)

• Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
• Percentage of Participants Who Achieve ≥25% Body Weight Reduction [ Time Frame: Week 72 ]
• Change from Baseline in Weight Circumference in Centimeter (cm) [ Time Frame: Baseline, Week 72 ]
• Percentage of Participants Who Achieve ≥30% Body Weight Reduction [ Time Frame: Week 72 ]
• Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Phase 3b

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Obesity
• Overweight

Intervention

• Drug: Tirzepatide
  Administered SC
  Other Name: LY3298176
• Drug: Semaglutide
  Administered SC

Study Arms

• Experimental: Tirzepatide
  Participants will receive tirzepatide subcutaneously (SC).
  Intervention: Drug: Tirzepatide
• Active Comparator: Semaglutide
  Participants will receive semaglutide SC.
  Intervention: Drug: Semaglutide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 10, 2023): 700
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 6, 2024
• Estimated Primary Completion Date: November 6, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States
• Removed Location Countries: Argentina, Belgium, Brazil, Canada, Germany, Poland, United Kingdom

Administrative Information

• NCT Number: NCT05822830
• Other Study ID Numbers: 17203; I8F-MC-GPHJ ( Other Identifier: Eli Lilly and Company ); U1111-1283-5404 ( Other Identifier: UTN Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Eli Lilly and Company
• Verification Date: March 2024