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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: LY3502970 Drug: Dulaglutide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo and Once-Weekly Dulaglutide in Participants With Type 2 Diabetes Mellitus
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : September 23, 2022
Estimated Study Completion Date : September 23, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3502970 Dose 1
Participants will receive escalated doses of LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 2
Participants will receive escalated doses of LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 3
Participants will receive escalated doses of LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 4
Participants will receive escalated doses of LY3502970 administered orally
 Drug: LY3502970
Administered orally
Experimental: LY3502970 Dose 5
Participants will receive escalated doses of LY3502970 administered orally
 Drug: LY3502970
Administered orally
Active Comparator: Dulaglutide
Participants will receive Dulaglutide subcutaneously (SC)
 Drug: Dulaglutide
Administered subcutaneously
Placebo Comparator: Placebo Matching LY3502970
Participants will receive placebo matching LY3502970 orally
 Drug: Placebo
Administered orally
Placebo Comparator: Placebo Matching Dulaglutide
Participants will receive placebo matching Dulaglutide subcutaneously
 Drug: Placebo
Administered subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c in LY3502970 and Dulaglutide [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in HbA1c in LY3502970 and Dulaglutide

  2. Percentage of Participants with HbA1c ≤ 6.5% [ Time Frame: Week 26 ]
    Percentage of Participants with HbA1c ≤ 6.5%

  3. Percentage of Participants with HbA1c <7.0% [ Time Frame: Week 26 ]
    Percentage of Participants with HbA1c <7.0%

  4. Percentage of Participants in Fasting Glucose [ Time Frame: Week 26 ]
    Percentage of Participants in Fasting Glucose

  5. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Body Weight

  6. Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of LY3502970 [ Time Frame: Baseline through Week 26 ]
    PK: Steady State AUC of LY3502970


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT05048719


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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05048719    
Other Study ID Numbers: 17787
J2A-MC-GZGE ( Other Identifier: Eli Lilly and Company )
2021-002806-29 ( EudraCT Number )
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 17, 2022
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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs