A phase 1 multiple-ascending dose study of tirzepatide in Japanese participants with type 2 diabetes.

Furihata K, Mimura H, Urva S, Oura T, Ohwaki K, Imaoka T

Diabetes, obesity & metabolism18 Nov 2021Cited by 49 (Europe PMC)

PMID34647404PMCIDPMC9299227DOI10.1111/dom.14572PepBankPUB-34647404

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, decreased appetite was among the most frequent treatment-emergent adverse events with tirzepatide, generally dose-dependent and mild.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide often lowered appetite; this was generally mild and rose with dose.
Peptide
Tirzepatide
Outcome
IncreaseDecreased appetite adverse events
Study
n = 48
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
5, 10 or 15 mg · subcutaneous · 8 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported treatment-emergent adverse events (AEs) were decreased appetite and gastrointestinal AEs, which were generally dose-dependent and mild in severity.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was tirzepatide safety and tolerability.
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740401
02HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, gastrointestinal events were among the most frequent treatment-emergent adverse events with tirzepatide, generally dose-dependent and mild.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide often caused gut side effects; these were generally mild and rose with dose.
Peptide
Tirzepatide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 48
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5, 10 or 15 mg · subcutaneous · 8 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported treatment-emergent adverse events (AEs) were decreased appetite and gastrointestinal AEs, which were generally dose-dependent and mild in severity.
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was tirzepatide safety and tolerability.
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740402
03HumanRandomized controlled trialPharmacokinetics
In Japanese adults with type 2 diabetes, the plasma half-life of tirzepatide was approximately 5 days.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide stayed in the blood with a half-life of about 5 days.
Peptide
Tirzepatide
Outcome
Not applicablePlasma half-life
Study
n = 48
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5, 10 or 15 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Half-life
≈ 5 days
plasma tirzepatide
Source sentences
Summary
The plasma tirzepatide concentration half-life was approximately 5 days.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740403
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, tirzepatide 5 mg decreased fasting plasma glucose versus placebo after 8 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 5 mg lowered fasting blood glucose more than placebo after 8 weeks.
Peptide
Tirzepatide
Outcome
DecreaseFasting plasma glucose vs placebo, 5 mg
Study
n = 48
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
LS mean decrease vs placebo
52.7 mg/dL
5 mg
Source sentences
Summary
After 8 weeks of treatment, fasting plasma glucose decreased from baseline with tirzepatide versus placebo; the least squares (LS) mean decrease compared with placebo (95% confidence interval [CI]) was 52.7 (35.9-69.6), 69.1 (52.3-85.9), and 68.9 (53.2-84.6) mg/dL in the 5-, 10-, and 15-mg treatment…
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740404
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, tirzepatide 10 mg decreased fasting plasma glucose versus placebo after 8 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 10 mg lowered fasting blood glucose more than placebo after 8 weeks.
Peptide
Tirzepatide
Outcome
DecreaseFasting plasma glucose vs placebo, 10 mg
Study
n = 48
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
LS mean decrease vs placebo
69.1 mg/dL
10 mg
Source sentences
Summary
After 8 weeks of treatment, fasting plasma glucose decreased from baseline with tirzepatide versus placebo; the least squares (LS) mean decrease compared with placebo (95% confidence interval [CI]) was 52.7 (35.9-69.6), 69.1 (52.3-85.9), and 68.9 (53.2-84.6) mg/dL in the 5-, 10-, and 15-mg treatment…
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740405
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, tirzepatide 15 mg decreased fasting plasma glucose versus placebo after 8 weeks.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 15 mg lowered fasting blood glucose more than placebo after 8 weeks.
Peptide
Tirzepatide
Outcome
DecreaseFasting plasma glucose vs placebo, 15 mg
Study
n = 48
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
LS mean decrease vs placebo
68.9 mg/dL
15 mg
Source sentences
Summary
After 8 weeks of treatment, fasting plasma glucose decreased from baseline with tirzepatide versus placebo; the least squares (LS) mean decrease compared with placebo (95% confidence interval [CI]) was 52.7 (35.9-69.6), 69.1 (52.3-85.9), and 68.9 (53.2-84.6) mg/dL in the 5-, 10-, and 15-mg treatment…
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740406
07HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, tirzepatide decreased HbA1c versus placebo at 8 weeks, by up to 1.6%.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide lowered HbA1c more than placebo after 8 weeks, by up to 1.6%.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change vs placebo at 8 weeks
Study
n = 48
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5, 10 or 15 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
LS mean HbA1c decrease vs placebo
≤ 1.6%
tirzepatide groups
Source sentences
Summary
Tirzepatide also resulted in LS mean decreases from baseline versus placebo at 8 weeks in HbA1c up to 1.6% (95% CI 1.2%-1.9%; P < .0001 for all treatment groups)
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740407
08HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, tirzepatide decreased body weight versus placebo at 8 weeks, by up to 6.6 kg.
In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide reduced body weight more than placebo after 8 weeks, by up to 6.6 kg.
Peptide
Tirzepatide
Outcome
DecreaseBody weight change vs placebo at 8 weeks
Study
n = 48
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
5, 10 or 15 mg · subcutaneous · 8 weeksAs given in this study (human).
Measurements
LS mean body weight decrease vs placebo
≤ 6.6 kg
tirzepatide groups
Source sentences
Summary
Tirzepatide also resulted in LS mean decreases from baseline versus placebo at 8 weeks in HbA1c up to 1.6% (95% CI 1.2%-1.9%; P < .0001 for all treatment groups) and body weight up to 6.6 kg (95% CI 5.3-7.9; P < .0001 for all treatment groups).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 1, double-blind, placebo-controlled, parallel-dose, multiple-ascending dose study randomized participants to once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3464740408

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 not yet recruiting · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 2/3NCT07734792

Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

yifang zhun = 726est. 20 Sept 2026 to est. 31 Jul 2028

Acute Ischemic Stroke (AIS)

Trial page ClinicalTrials.govUpdated 1 Oct 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 12:58 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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MeSH terms

Keywords

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