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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4)

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ClinicalTrials.gov Identifier: NCT04660643
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 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 : 750 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 for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : August 3, 2023
Estimated Study Completion Date : August 31, 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
Placebo administered SC
Other: Placebo
Administered SC




Primary Outcome Measures :
  1. Percent Change from Randomization (Week 36) in Body Weight [ Time Frame: Randomization, Week 88 ]
    Percent change from randomization in body weight


Secondary Outcome Measures :
  1. Change from Randomization in Body Weight [ Time Frame: Randomization, Week 88 ]
    Change from randomization in body weight

  2. Change from Randomization in Waist Circumference [ Time Frame: Randomization, Week 88 ]
    Change from randomization in waist circumference

  3. Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During the Open-Label Period [ Time Frame: Week 88 ]
    Percentage of participants who maintain ≥80% of the body weight lost during the open-label period

  4. Percentage of Participants Who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 88 ]
    Percentage of participants who achieve ≥5% body weight reduction

  5. Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 88 ]
    Percentage of participants who achieve ≥10% body weight reduction

  6. Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% during the Open-Label Period [ Time Frame: Randomization, Week 88 ]
    Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label period

  7. Percent Change from Randomization in Body Weight [ Time Frame: Randomization, Week 64 ]
    Percent change from randomization in body weight

  8. Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, Week 88 ]
    Change from randomization in BMI

  9. Change from Randomization in Fasting Glucose [ Time Frame: Randomization, Week 88 ]
    Change from randomization in fasting glucose

  10. Change from Randomization in Hemoglobin A1c (HbA1c) [ Time Frame: Randomization, Week 88 ]
    Change from randomization in HbA1c

  11. Change from Randomization in Fasting Insulin [ Time Frame: Randomization, Week 88 ]
    Change from randomization in fasting insulin

  12. Change from Randomization in Total Cholesterol [ Time Frame: Randomization, Week 88 ]
    Change from randomization in total cholesterol

  13. Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Randomization, Week 88 ]
    Change from randomization in LDL cholesterol

  14. Change from Randomization in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: Randomization, Week 88 ]
    Change from randomization in HDL cholesterol

  15. Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Randomization, Week 88 ]
    Change from randomization in VLDL cholesterol

  16. Change from Randomization in Triglycerides [ Time Frame: Randomization, Week 88 ]
    Change from randomization in triglycerides

  17. Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, Week 88 ]
    Change from randomization in free fatty acids

  18. Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, Week 88 ]
    Change from randomization in SBP

  19. Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, Week 88 ]
    Change from randomization in DBP

  20. Change from Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Randomization, Week 88 ]
    The 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.

  21. 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, Week 88 ]
    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.

  22. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 88 ]
    Change from baseline in body weight

  23. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 88 ]
    Percent change from baseline in body weight

  24. Change from Baseline in BMI [ Time Frame: Baseline, Week 88 ]
    Change from baseline in BMI

  25. Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 88 ]
    Percentage of participants who achieve ≥15% body weight reduction

  26. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 88 ]
    Change from baseline in waist circumference

  27. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 88 ]
    Change from baseline in fasting glucose

  28. Change from Baseline in HbA1c [ Time Frame: Baseline, Week 88 ]
    Change from baseline in HbA1c

  29. Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 88 ]
    Change from baseline in fasting insulin

  30. Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 88 ]
    Change from baseline in total cholesterol

  31. Change from Baseline in HDL Cholesterol [ Time Frame: Baseline, Week 88 ]
    Change from baseline in HDL cholesterol

  32. Change from Baseline in LDL Cholesterol [ Time Frame: Baseline, Week 88 ]
    Change from baseline in LDL cholesterol

  33. Change from Baseline in VLDL Cholesterol [ Time Frame: Baseline, Week 88 ]
    Change from baseline in VLDL cholesterol

  34. Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 88 ]
    Change from baseline in triglycerides

  35. Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 88 ]
    Change from baseline in free fatty acids

  36. Change from Baseline in SBP [ Time Frame: Baseline, Week 88 ]
    Change from baseline in SBP

  37. Change from Baseline in DBP [ Time Frame: Baseline, Week 88 ]
    Change from baseline in DBP

  38. Change from Randomization in SF 36v2 Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, Week 88 ]
    The SF-36v2 acute form, 1-week recall assesses participants' 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.

  39. Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score [ Time Frame: Baseline, Week 88 ]
    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.



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:

  • Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, 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): NCT04660643


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 72 study locations
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: NCT04660643    
Other Study ID Numbers: 17247
I8F-MC-GPHN ( Other Identifier: Eli Lilly and Company )
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021
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: 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:
Metabolism and Nutrition Disorder
Prediabetes
Additional relevant MeSH terms:
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Obesity
Overweight
Weight Loss
Overnutrition
Nutrition Disorders
Body Weight
Body Weight Changes
LY3298176
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists