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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 : Recruiting
First Posted : December 7, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 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
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10 mg Tirzepatide
10 mg Tirzepatide administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 15 mg Tirzepatide
15 mg Tirzepatide administered 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 in Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Percent Change from randomization in body weight

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve ≥5% body weight reduction from randomization


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

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

  3. Change from Randomization in Absolute Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in absolute body weight

  4. Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in BMI

  5. Change from Randomization in HbA1c [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HbA1c

  6. Percentage of Participants who Achieve HbA1c <7% [ Time Frame: 72 Weeks ]
    Percentage of Participants who Achieve HbA1c <7%

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

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

  9. Change from Randomization in Fasting Glucose [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting glucose

  10. Change from Randomization in Waist Circumference [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in waist circumference

  11. Change from Randomization in Total Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in total cholesterol

  12. Change from Randomization in Low Density Lipid (LDL)-Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in LDL-cholesterol

  13. Change from Randomization in High Density Lipid (HDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HDL cholesterol

  14. Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in VLDL cholesterol

  15. Change from Randomization in Triglycerides [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in triglycerides

  16. Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in free fatty acids

  17. Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in SBP

  18. Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in DBP

  19. Change from Randomization in Fasting Insulin [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting insulin

  20. Change from Randomization in Short Form 36 Health Survey version 2 (SF-36v2) acute form Physical Functioning domain score [ Time Frame: Randomization, 72 Weeks ]
    The Short Form 36 Version 2 (SF-36v2 ) acute form, 1-week recall, assesses participants' health-related quality of life (HRQoL) on 8 domains: 1) limitations in physical functioning; 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, 72 Weeks ]
    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. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 72 ]
    PK: Steady State AUC of Tirzepatide



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:

  • 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

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


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
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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
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
Last Update Posted: November 22, 2021
Last Verified: November 15, 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:

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://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
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists