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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

Tracking Information
First Submitted Date  ICMJE December 2, 2019
First Posted Date  ICMJE December 3, 2019
Last Update Posted Date April 13, 2022
Actual Study Start Date  ICMJE December 4, 2019
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]
    Percent Change from Baseline in Body Weight
  • Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥5% Body Weight Reduction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2021)
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in Body Weight
  • Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 176 ]
    Percent Change from Baseline in Body Weight
  • Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥10% Body Weight Reduction
  • Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥15% Body Weight Reduction
  • Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 176 ]
    Percentage of Participants who Achieve ≥5% Body Weight Reduction
  • Percentage of Participants who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥20% Body Weight Reduction
  • Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Waist Circumference
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in BMI
  • Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Glucose
  • Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Insulin
  • Time to Onset of Type 2 Diabetes [ Time Frame: Baseline through Week 176 ]
    Time to Onset of Type 2 Diabetes
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HbA1c
  • Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Triglycerides
  • Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in LDL Cholesterol
  • Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Total Cholesterol
  • Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HDL Cholesterol
  • Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in VLDL Cholesterol
  • Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Free Fatty Acids
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Systolic Blood Pressure
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Diastolic Blood Pressure
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in Body Weight
  • Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 176 ]
    Percent Change from Baseline in Body Weight
  • Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥10% Body Weight Reduction
  • Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
    Percentage of Participants who Achieve ≥15% Body Weight Reduction
  • Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 176 ]
    Percentage of Participants who Achieve ≥5% Body Weight Reduction
  • Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Waist Circumference
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in BMI
  • Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Glucose
  • Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Fasting Insulin
  • Time to Onset of Type 2 Diabetes [ Time Frame: Baseline through Week 176 ]
    Time to Onset of Type 2 Diabetes
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HbA1c
  • Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Triglycerides
  • Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in LDL Cholesterol
  • Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Total Cholesterol
  • Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in HDL Cholesterol
  • Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in VLDL Cholesterol
  • Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Free Fatty Acids
  • Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Systolic Blood Pressure
  • Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Week 72 ]
    Change from Baseline in Diastolic Blood Pressure
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: 5 mg Tirzepatide
    5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
    Intervention: Drug: Tirzepatide
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once a week.
    Intervention: Drug: Tirzepatide
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once a week.
    Intervention: Drug: Tirzepatide
  • Placebo Comparator: Placebo
    Placebo administered SC once a week.
    Intervention: Drug: Placebo
Publications * Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 2, 2021)
2539
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
2400
Estimated Study Completion Date  ICMJE May 24, 2024
Actual Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   China,   India,   Japan,   Mexico,   Puerto Rico,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04184622
Other Study ID Numbers  ICMJE 17244
I8F-MC-GPHK ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
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  ICMJE
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 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  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP