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Trial record 4 of 10 for:    lilly AND "basal insulin" | Phase 1

A Study of LY3192767 in Healthy Participants

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: NCT03025009
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3192767 Drug: Basal Insulin Peglispro Drug: Insulin Glargine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 11, 2018

Arm Intervention/treatment
Experimental: LY3192767 (Part A)
Escalating doses of LY3192767 administered subcutaneously (SC).
Drug: LY3192767
Administered SC.

Placebo Comparator: Placebo (Part A)
Placebo matching LY3192767 administered subcutaneously (SC).
Drug: Placebo
Administered SC.

Experimental: LY3192767 (Part B)
LY3192767 administered as a SC injection in one of three study periods.
Drug: LY3192767
Administered SC.

Active Comparator: Basal Insulin Peglispro (Part B)
Basal insulin peglispro administered as a SC injection in one of three study periods.
Drug: Basal Insulin Peglispro
Administered SC.
Other Name: LY2605541

Active Comparator: Insulin Glargine (Part B)
Insulin glargine administered as a SC injection in one of three study periods.
Drug: Insulin Glargine
Administered SC.




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 Administration [ Time Frame: Baseline through Study Completion (up to about Day 49) ]
    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): Time to Maximum Concentration (Tmax) of LY3192767 [ Time Frame: Predose through 336 Hours ]
    PK: Tmax of LY3192767

  2. PK: Maximum Serum Concentration (Cmax) of LY3192767 [ Time Frame: Predose through 336 Hours ]
    PK: Cmax of LY3192767

  3. PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767 [ Time Frame: Predose through 336 Hours ]
    PK: AUC(0-inf) of LY3192767

  4. Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767 [ Time Frame: Predose through 36 Hours During Clamp Procedure ]
    PD: Total Amount of Glucose Infused (Gtot) of LY3192767

  5. PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767 [ Time Frame: Predose through 36 Hours During Clamp Procedure ]
    PD: Rmax of LY3192767

  6. PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767 [ Time Frame: Predose through 36 Hours During Clamp Procedure ]
    PD: TRmax of LY3192767

  7. PD: Change from Baseline in Free Fatty Acids [ Time Frame: Predose through 48 Hours Postdose ]
    PD: Change from Baseline in Free Fatty Acids

  8. PD: Change from Baseline in Glycerol [ Time Frame: Predose through 48 Hours Postdose ]
    PD: Change from Baseline in Glycerol

  9. PD: Change from Baseline in Triglycerides [ Time Frame: Predose through 48 Hours Postdose ]
    PD: Change from Baseline in Triglycerides



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
  • Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
  • Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

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): NCT03025009


Locations
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Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03025009    
Other Study ID Numbers: 16242
I8M-MC-BIXA ( Other Identifier: Eli Lilly and Company )
2016-003274-40 ( EudraCT Number )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
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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Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs