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A Study of Tirzepatide (LY3298176) in Japanese 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: NCT03322631
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purposes of this study are to determine:

  • The safety of tirzepatide and any side effects that might be associated with it.
  • How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
  • How tirzepatide affects the levels of blood sugar.

This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Ascending Dose Study in Japanese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC).
Drug: Tirzepatide
Administered SC.
Other Name: LY3298176

Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
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 Day 85 ]
    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 Concentration (Cmax) of Tirzepatide [ Time Frame: Baseline through Day 85 ]
    PK: Cmax of tirzepatide

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Day 85 ]
    PK: AUC of tirzepatide

  3. Pharmacodynamics (PD): Change from Baseline to 8 Weeks in Fasting Plasma Glucose [ Time Frame: Baseline, Week 8 ]
    PD: Change from Baseline to 8 Weeks in Fasting Plasma Glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)
  • Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

Exclusion Criteria:

  • Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
  • Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors

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): NCT03322631


Locations
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Japan
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.
Hachioji, Tokyo, Japan, 192-0071
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.
Shinjuku-Ku, Tokyo, Japan, 169-0073
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: NCT03322631    
Other Study ID Numbers: 16400
I8F-JE-GPGC ( Other Identifier: Eli Lilly and Company )
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 15, 2019

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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
LY3298176
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists