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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight (SURMOUNT-2)

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ClinicalTrials.gov Identifier: NCT04657003
Recruitment Status : Completed
First Posted : December 7, 2020
Results First Posted : April 8, 2024
Last Update Posted : April 8, 2024
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 type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Overweight Obesity Drug: Tirzepatide Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 938 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 With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : March 16, 2023
Actual Study Completion Date : April 10, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 10 milligrams (mg) Tirzepatide
10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: 15 mg Tirzepatide
15 mg Tirzepatide administered SC QW
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Placebo Comparator: Placebo
Placebo administered SC QW
 Other: 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 Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline [ Time Frame: Week 72 ]
    Percentage of participants who achieve ≥5% body weight reduction from baseline


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline [ Time Frame: Week 72 ]
    Percentage of participants who achieve ≥10% body weight reduction from baseline

  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline [ Time Frame: Week 72 ]
    Percentage of participants who achieve ≥15% body weight reduction from baseline

  3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline [ Time Frame: Week 72 ]
    Percentage of participants who achieve ≥20% body weight reduction from baseline

  4. Change From Baseline in Absolute Body Weight [ Time Frame: Baseline, Week 72 ]
    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  5. Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  6. Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]
    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  7. Percentage of Participants Who Achieve HbA1c <7% [ Time Frame: Week 72 ]
    Percentage of participants who achieve HbA1c <7%

  8. Percentage of Participants Who Achieve HbA1c ≤6.5% [ Time Frame: Week 72 ]
    Percentage of participants who achieve HbA1c ≤6.5%

  9. Percentage of Participants Who Achieve HbA1c <5.7% [ Time Frame: Week 72 ]
    Percentage of participants who achieve HbA1c <5.7%

  10. Change From Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

  11. Change From Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

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

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

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

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

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

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

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

  19. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) [ Time Frame: Baseline, Week 72 ]
    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  20. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) [ Time Frame: Baseline, Week 72 ]
    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  21. Percent Change From Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  22. Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [ 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.

  23. 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 ]
    The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (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.

  24. Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide [ Time Frame: Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose ]
    Each participant was 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. The steady state AUC was evaluated using Population PK modeling.


Eligibility Criteria
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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 Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
  • Have a BMI of ≥27 kg/m²
  • Are overweight or have obesity
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
  • Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria:

  • Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
  • Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
  • Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
  • Have self-reported change in body weight >5kg within 3 months prior to screening
  • Have had a history of chronic or acute pancreatitis
  • 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
  • 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): NCT04657003


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] November 23, 2020
Statistical Analysis Plan  [PDF] January 13, 2023

More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04657003    
Other Study ID Numbers: 17245
I8F-MC-GPHL ( Other Identifier: Eli Lilly and Company )
First Posted: December 7, 2020    Key Record Dates
Results First Posted: April 8, 2024
Last Update Posted: April 8, 2024
Last Verified: March 2024
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:

Time Frame:

Data are available 6 months after the primary publication or 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://www.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
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
 Nutrition Disorders
Body Weight
Tirzepatide
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs