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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

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: NCT04184622
Recruitment Status : Active, not recruiting
First Posted : December 3, 2019
Last Update Posted : April 13, 2022
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 overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2539 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Actual Study Start Date : December 4, 2019
Actual Primary Completion Date : April 1, 2022
Estimated Study Completion Date : May 24, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Placebo Comparator: Placebo
Placebo administered SC once a week.
 Drug: Placebo
Administered SC


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

  2. Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥5% Body Weight Reduction


Secondary Outcome Measures :
  1. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in Body Weight

  2. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 176 ]
    Percent Change from Baseline in Body Weight

  3. Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥10% Body Weight Reduction

  4. Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥15% Body Weight Reduction

  5. Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 176 ]
    Percentage of Participants who Achieve ≥5% Body Weight Reduction

  6. Percentage of Participants who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥20% Body Weight Reduction

  7. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Waist Circumference

  8. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in BMI

  9. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Glucose

  10. Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Insulin

  11. Time to Onset of Type 2 Diabetes [ Time Frame: Baseline through Week 176 ]
    Time to Onset of Type 2 Diabetes

  12. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HbA1c

  13. Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Triglycerides

  14. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in LDL Cholesterol

  15. Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Total Cholesterol

  16. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HDL Cholesterol

  17. Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in VLDL Cholesterol

  18. Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Free Fatty Acids

  19. Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Systolic Blood Pressure

  20. Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Diastolic Blood Pressure

  21. Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score

  22. 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, Week 72 ]
    Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score

  23. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 72 ]
    PK: Steady State AUC of Tirzepatide


Eligibility Criteria
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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
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): NCT04184622


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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04184622    
Other Study ID Numbers: 17244
I8F-MC-GPHK ( Other Identifier: Eli Lilly and Company )
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
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 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
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