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A Study of LY3305677 in Participants With Type 2 Diabetes

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: NCT03928379
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : July 19, 2021
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 learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY3305677 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Ascending Dose Study in Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
Actual Study Start Date : October 27, 2019
Actual Primary Completion Date : July 8, 2021
Actual Study Completion Date : July 8, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3305677
LY3305677 administered SC
 Drug: LY3305677
Administered SC
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [ Time Frame: Baseline through 24 weeks ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677 [ Time Frame: Baseline through 48 hours postdose ]
    PK: Cmax of LY3305677

  2. PK: Area Under the Concentration-Time Curve (AUC) of LY3305677 [ Time Frame: Baseline through 48 hours postdose ]
    PK: AUC of LY3305677

  3. Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose [ Time Frame: Baseline, through Week 16 ]
    PD: Change from Baseline in Fasting Plasma Glucose

  4. PD: Change from Baseline in Fasting Plasma Insulin [ Time Frame: Baseline, through Week 16 ]
    PD: Change from Baseline in Fasting Plasma Insulin


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Type II diabetes
  • Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
  • Have a body weight of <150 kilograms (kg)
  • Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.

Exclusion Criteria:

  • Have Type 1 diabetes or latent autoimmune diabetes in adults
  • Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
  • Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
  • Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
  • Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
  • Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)
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): NCT03928379


Locations
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Germany
Profil Institut für Stoffwechselforschung
Neuss, Nordrhein-Westfalen, Germany, 41460
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: NCT03928379    
Other Study ID Numbers: 17011
I8P-MC-OXAD ( Other Identifier: Eli Lilly and Company )
2018-004779-11 ( EudraCT Number )
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases