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A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

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: NCT05048719
Recruitment Status : Active, not recruiting
First Posted : September 17, 2021
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 13, 2021
First Posted Date  ICMJE September 17, 2021
Last Update Posted Date June 22, 2022
Actual Study Start Date  ICMJE September 15, 2021
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
Change from Baseline in Hemoglobin A1c (HbA1c) in LY3502970 and Placebo [ Time Frame: Baseline, Week 26 ]
Change from Baseline in HbA1c in LY3502970 and Placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2021)
  • Change from Baseline in HbA1c in LY3502970 and Dulaglutide [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c in LY3502970 and Dulaglutide
  • Percentage of Participants with HbA1c ≤ 6.5% [ Time Frame: Week 26 ]
    Percentage of Participants with HbA1c ≤ 6.5%
  • Percentage of Participants with HbA1c <7.0% [ Time Frame: Week 26 ]
    Percentage of Participants with HbA1c <7.0%
  • Percentage of Participants in Fasting Glucose [ Time Frame: Week 26 ]
    Percentage of Participants in Fasting Glucose
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Body Weight
  • Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [ Time Frame: Baseline through Week 26 ]
    PK: Steady State AUC of LY3502970
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 LY3502970 in Participants With Type 2 Diabetes Mellitus
Official Title  ICMJE A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus
Brief Summary The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: LY3502970
    Administered orally
  • Drug: Dulaglutide
    Administered subcutaneously
  • Drug: Placebo
    Administered orally
  • Drug: Placebo
    Administered subcutaneously
Study Arms  ICMJE
  • Experimental: LY3502970 Dose 1
    Participants will receive escalated doses of LY3502970 administered orally
    Intervention: Drug: LY3502970
  • Experimental: LY3502970 Dose 2
    Participants will receive escalated doses of LY3502970 administered orally
    Intervention: Drug: LY3502970
  • Experimental: LY3502970 Dose 3
    Participants will receive escalated doses of LY3502970 administered orally
    Intervention: Drug: LY3502970
  • Experimental: LY3502970 Dose 4
    Participants will receive escalated doses of LY3502970 administered orally
    Intervention: Drug: LY3502970
  • Experimental: LY3502970 Dose 5
    Participants will receive escalated doses of LY3502970 administered orally
    Intervention: Drug: LY3502970
  • Active Comparator: Dulaglutide
    Participants will receive Dulaglutide subcutaneously (SC)
    Intervention: Drug: Dulaglutide
  • Placebo Comparator: Placebo Matching LY3502970
    Participants will receive placebo matching LY3502970 orally
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo Matching Dulaglutide
    Participants will receive placebo matching Dulaglutide subcutaneously
    Intervention: Drug: 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: September 13, 2021)
370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 23, 2022
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
  • Have a stable body weight for the 3 months prior to randomization
  • Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
  • Males must agree to use highly effective methods of contraception
  • Women not of childbearing potential (WNOCBP) may participate in this trial
  • Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

Exclusion Criteria:

  • Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
  • Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
  • Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
  • Have acute or chronic pancreatitis
  • Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
  • Have gastric emptying abnormality or chronically take medications impacting GI motility
  • Have poorly controlled hypertension
  • Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
  • Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
  • Have HIV, or Hepatitis B or Hepatitis C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 Hungary,   Poland,   Puerto Rico,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05048719
Other Study ID Numbers  ICMJE 17787
J2A-MC-GZGE ( Other Identifier: Eli Lilly and Company )
2021-002806-29 ( EudraCT Number )
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: 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 June 17, 2022

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