Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

NCTNCT03322631Other id16400Other idI8F-JE-GPGC

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 48 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 1 country
Japan
Start: 15 Nov 2017
Primary completion: 29 May 2018
Completion: 28 Nov 2018
First posted: 26 Oct 2017
Last update posted: 23 Mar 2023
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 1
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
NCT03322631
15 Nov 2017 to 28 Nov 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TirzepatideDrug
PlaceboDrug

Arms2

Experimental
Tirzepatide
Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall.
Placebo comparator
Placebo
Participants received placebo administered into the SC tissue of the abdominal wall.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

Secondary outcomes(3)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide
Time frame · Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Registry description
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide
Time frame · Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Registry description
Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\[0- τ\]), where tau is dosing interval of (0-168 hours).
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose
Time frame · Baseline, Week 8
Registry description
Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline through Day 85

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Group	Value (Participants)
Placebo	0
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)	0
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)	0
5 mg Tirzepatide (Cohort 3)	0

Secondary and other outcome results(3)

Secondary outcomeGeometric mean· Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide

Group	Value (nanograms per milliliter (ng/mL))	Spread
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)	215	18
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)	442	23
5 mg Tirzepatide (Cohort 3)	364	20

Secondary outcomeGeometric mean· Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration

PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide

Group	Value (nanograms * hours per mL (ng*hr/mL))	Spread
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)	26100	27
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)	54400	16
5 mg Tirzepatide (Cohort 3)	48800	16

Secondary outcomeMean· Baseline, Week 8

Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose

Group	Value (milligram per deciliter (mg/dL))	Spread
Placebo	-4.0	23.7
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)	-77.5	24.2
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)	-72.6	30.9
5 mg Tirzepatide (Cohort 3)	-51.7	28.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received placebo administered into the SC tissue of the abdominal wall.	0 / 9	0 / 9	4 / 9
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)Participants received tirzepatide with titration regimen starting from 2.5 mg (milligrams) for Days 1 and 8 followed by 5 mg for Days 15 and 22, and 10 mg for Days 29, 36, 43, and 50 administered into the subcutaneous (SC) tissue of the abdominal wall.	0 / 12	0 / 12	11 / 12
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)Participants received tirzepatide with titration regimen starting from 5 mg for Days 1 and 8 followed by 10 mg for Days 15, 22, 29, and 36, and 15 mg for Days 43 and 50 administered into the SC tissue of the abdominal wall.	0 / 16	0 / 16	15 / 16
5 mg Tirzepatide (Cohort 3)Participants received 5 mg tirzepatide administered into the SC tissue of the abdominal wall.	0 / 11	0 / 11	6 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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