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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
Results First Posted : April 24, 2023
Last Update Posted : April 24, 2023
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. 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 : August 4, 2020
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 ]
    Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  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 (Pooled Doses of Tirzepatide 10 mg and 15 mg) [ Time Frame: Baseline, Week 20 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  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 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  8. Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  9. Change From Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  10. Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  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 ]
    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 calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  13. Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.

  14. Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

  15. Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

  16. Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

  17. Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

  18. Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimate and SE from MMRM analysis using log transformation.

  19. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  20. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment*time (Type III sum of squares) in the model.

  21. Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) [ Time Frame: Baseline, Week 72 ]
    The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 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" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

  22. Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 [ Time Frame: Baseline, Week 72 ]
    The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (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 quality of life.

  23. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose ]
    PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.


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:

  • 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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] October 4, 2021
Statistical Analysis Plan  [PDF] September 28, 2021

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
Results First Posted: April 24, 2023
Last Update Posted: April 24, 2023
Last Verified: March 7, 2023
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