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A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)

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ClinicalTrials.gov Identifier: NCT04657016
Recruitment Status : Completed
First Posted : December 7, 2020
Results First Posted : May 16, 2024
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : April 20, 2023
Actual Study Completion Date : May 12, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide
Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Placebo Comparator: Placebo
Participants received matching placebo SC once weekly (QW).
 Other: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.


Secondary Outcome Measures :
  1. Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program [ Time Frame: 72 Weeks ]
    Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  2. Percentage of Participants Who Achieve ≥10%Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  4. Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  5. Change From Baseline in Waist Circumference [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  6. Change From Baseline in Body Weight [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

  7. Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

  8. Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  9. Change From Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  10. Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  11. Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  12. Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  13. Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  14. Percent Change From Baseline in Triglycerides [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  15. Percent Change From Baseline in Free Fatty Acids [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  16. Change From Baseline in Fasting Glucose [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  17. Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 72 Weeks ]
    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  18. Percent Change From Baseline in Fasting Insulin [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  19. Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, 72 Weeks ]

    The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.

    LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.


  20. Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score [ Time Frame: Baseline, 72 Weeks ]

    The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life.

    LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
  • History of at least one 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
  • Any lifetime history of a suicide attempt
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): NCT04657016


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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] November 19, 2020
Statistical Analysis Plan  [PDF] February 3, 2023

More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04657016    
Other Study ID Numbers: 17246
I8F-MC-GPHM ( Other Identifier: Eli Lilly and Company )
First Posted: December 7, 2020    Key Record Dates
Results First Posted: May 16, 2024
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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:

Access Criteria:

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://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:
Diet
Exercise
Metabolism and Nutrition Disorder
Behavioral Modification
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Tirzepatide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs