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

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: NCT04657003
Recruitment Status : Active, not recruiting
First Posted : December 7, 2020
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 1, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date April 19, 2022
Actual Study Start Date  ICMJE March 29, 2021
Estimated Primary Completion Date March 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Percent Change from Randomization in Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Percent Change from randomization in body weight
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • 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
  • 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
  • Change from Randomization in Absolute Body Weight [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in absolute body weight
  • Change from Randomization in Body Mass Index (BMI) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in BMI
  • Change from Randomization in HbA1c [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HbA1c
  • Percentage of Participants who Achieve HbA1c <7% [ Time Frame: 72 Weeks ]
    Percentage of Participants who Achieve HbA1c <7%
  • Percentage of Participants Who Achieve HbA1c ≤6.5% [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve HbA1c ≤6.5%
  • Percentage of Participants Who Achieve HbA1c <5.7% [ Time Frame: 72 Weeks ]
    Percentage of participants who achieve HbA1c <5.7%
  • Change from Randomization in Fasting Glucose [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting glucose
  • Change from Randomization in Waist Circumference [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in waist circumference
  • Change from Randomization in Total Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in total cholesterol
  • Change from Randomization in Low Density Lipid (LDL)-Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in LDL-cholesterol
  • Change from Randomization in High Density Lipid (HDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in HDL cholesterol
  • Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in VLDL cholesterol
  • Change from Randomization in Triglycerides [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in triglycerides
  • Change from Randomization in Free Fatty Acids [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in free fatty acids
  • Change from Randomization in Systolic Blood Pressure (SBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in SBP
  • Change from Randomization in Diastolic Blood Pressure (DBP) [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in DBP
  • Change from Randomization in Fasting Insulin [ Time Frame: Randomization, 72 Weeks ]
    Change from randomization in fasting insulin
  • 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.
  • 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.
  • Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 72 ]
    PK: Steady State AUC of Tirzepatide
Original Secondary Outcome Measures  ICMJE Same as current
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 Type 2 Diabetes Who Have Obesity or Are Overweight
Official Title  ICMJE 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)
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).
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
  • Type 2 Diabetes
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Other: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: 10 mg Tirzepatide
    10 mg Tirzepatide administered subcutaneously (SC)
    Intervention: Drug: Tirzepatide
  • Experimental: 15 mg Tirzepatide
    15 mg Tirzepatide administered SC
    Intervention: Drug: Tirzepatide
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Other: Placebo
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: December 1, 2020)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 17, 2023
Estimated Primary Completion Date March 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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,   India,   Japan,   Puerto Rico,   Russian Federation,   Taiwan,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT04657003
Other Study ID Numbers  ICMJE 17245
I8F-MC-GPHL ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
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:

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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
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