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

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: NCT04657016
Recruitment Status : Active, not recruiting
First Posted : December 7, 2020
Last Update Posted : March 23, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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
Estimated Primary Completion Date : April 13, 2023
Estimated Study Completion Date : May 11, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Administered SC
Other: Placebo
Administered SC




Primary Outcome Measures :
  1. Percent Change from Randomization in Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Percent change from randomization in body weight

  2. Percentage of Participants with ≥5% Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants with ≥5% body weight reduction


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

  2. Percentage of Participants Who Achieve ≥10%Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥10% body weight reduction

  3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥15% body weight reduction

  4. Change from Randomization in Waist Circumference [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in waist circumference

  5. Change from Randomization in Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in body weight

  6. Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in BMI

  7. Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in SBP

  8. Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in DBP

  9. Change from Randomization in Total Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in total cholesterol

  10. Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HDL

  11. Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in LDL

  12. Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in VLDL

  13. Change from Randomization in Triglycerides [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in triglycerides

  14. Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in free fatty acids

  15. Change from Randomization in Fasting Glucose [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting glucose

  16. Change from Randomization in HbA1c [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HbA1c

  17. Change from Randomization in Fasting Insulin [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting insulin

  18. Change from Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Randomization, 72 Weeks ]
    The Short Form 36 Version 2 (SF-36v2) acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains; 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health.

  19. Change from Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL) Lite CT Physical Function Composite Score [ Time Frame: Randomization, 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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.

  20. Change from Baseline in Absolute Body Weight [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in absolute body weight

  21. Percent Change From Baseline in Body Weight [ Time Frame: Baseline, 72 Weeks ]
    Percent change from baseline in body weight

  22. Change from Baseline in BMI [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in BMI

  23. Change from Baseline in Waist Circumference [ Time Frame: Baseline, 72 Weeks ]
    Change from baseline in waist circumference



Information from the National Library of Medicine

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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

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
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
Last Update Posted: March 23, 2022
Last Verified: March 15, 2022
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
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists