A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes.

Feng P, Sheng X, Ji Y, Urva S, Wang F, Miller S, Qian C, An Z, Cui Y

Advances in therapy7 Jun 2023Cited by 18 (Europe PMC)

PMID37285081PMCIDPMC10329955DOI10.1007/s12325-023-02536-8PepBankPUB-37285081

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. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, diarrhea was one of the most frequently reported treatment-emergent adverse events with tirzepatide.
In plain wordsIn Chinese patients with type 2 diabetes, diarrhea was one of the most common side effects of tirzepatide.
Peptide
Tirzepatide
Outcome
Direction not reportedDiarrhea (treatment-emergent adverse event)
Study
n = 20
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.5-10.0 mg or 2.5-15.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The most frequently reported treatment-emergent adverse events (TEAEs) among patients receiving tirzepatide were diarrhea and decreased appetite; most TEAEs were mild and resolved spontaneously with no serious adverse events reported in the tirzepatide groups and one in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508101
02HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, decreased appetite was one of the most frequently reported treatment-emergent adverse events with tirzepatide.
In plain wordsIn Chinese patients with type 2 diabetes, reduced appetite was one of the most common side effects of tirzepatide.
Peptide
Tirzepatide
Outcome
Direction not reportedDecreased appetite (treatment-emergent adverse event)
Study
n = 20
Outcome group
Adverse events · Whole body
Studied dose
2.5-10.0 mg or 2.5-15.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
The most frequently reported treatment-emergent adverse events (TEAEs) among patients receiving tirzepatide were diarrhea and decreased appetite; most TEAEs were mild and resolved spontaneously with no serious adverse events reported in the tirzepatide groups and one in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508102
03HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, most treatment-emergent adverse events with tirzepatide were mild and resolved spontaneously.
In plain wordsIn Chinese patients with type 2 diabetes, most side effects of tirzepatide were mild and went away on their own.
Peptide
Tirzepatide
Outcome
Not applicableSeverity of treatment-emergent adverse events
Study
n = 20
Outcome group
Adverse events · Whole body
Studied dose
2.5-10.0 mg or 2.5-15.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
most TEAEs were mild and resolved spontaneously with no serious adverse events reported in the tirzepatide groups and one in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508103
04HumanRandomized controlled trialSafety outcome
In Chinese patients with type 2 diabetes, no serious adverse events were reported in the tirzepatide groups.
In plain wordsIn Chinese patients with type 2 diabetes, no serious side effects were reported in the tirzepatide groups.
Peptide
Tirzepatide
Outcome
No significant changeSerious adverse events
Study
n = 20
Outcome group
Adverse events · Whole body
Studied dose
2.5-10.0 mg or 2.5-15.0 mg once weekly · subcutaneousAs given in this study (human).
Source sentences
Summary
no serious adverse events reported in the tirzepatide groups and one in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508104
05HumanRandomized controlled trialPharmacokinetics
In Chinese patients with type 2 diabetes, the plasma half-life of tirzepatide was approximately 5-6 days.
In plain wordsIn Chinese patients with type 2 diabetes, tirzepatide stayed in the blood with a half-life of about 5 to 6 days.
Peptide
Tirzepatide
Outcome
Not applicablePlasma half-life of tirzepatide
Study
n = 20
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.5-10.0 mg or 2.5-15.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
Plasma half-life
5 to 6 days
tirzepatide
Source sentences
Summary
The plasma concentration half-life of tirzepatide was approximately 5-6 days.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508105
06HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, HbA1c fell by 2.4% from baseline at week 16 in the tirzepatide 2.5-10.0 mg group, while it stayed steady with placebo.
In plain wordsIn Chinese patients with type 2 diabetes, HbA1c fell after 16 weeks of tirzepatide, but stayed steady with placebo.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change in 2.5-10.0 mg group at week 16
Study
n = 10
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5-10.0 mg once weekly · subcutaneous · 16 weeksAs given in this study (human).
Measurements
HbA1c reduction from baseline
2.4%
tirzepatide 2.5-10.0 mg, week 16
Source sentences
Summary
Mean glycated hemoglobin (HbA1c) decreased over time from baseline in the 2.5-10.0 mg (- 2.4%) and 2.5-15.0 mg (- 1.6%) tirzepatide groups, at week 16 and week 24, respectively, but remained steady in patients receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508106
07HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, HbA1c fell by 1.6% from baseline at week 24 in the tirzepatide 2.5-15.0 mg group, while it stayed steady with placebo.
In plain wordsIn Chinese patients with type 2 diabetes, HbA1c fell after 24 weeks of tirzepatide, but stayed steady with placebo.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change in 2.5-15.0 mg group at week 24
Study
n = 10
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5-15.0 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
HbA1c reduction from baseline
1.6%
tirzepatide 2.5-15.0 mg, week 24
Source sentences
Summary
Mean glycated hemoglobin (HbA1c) decreased over time from baseline in the 2.5-10.0 mg (- 2.4%) and 2.5-15.0 mg (- 1.6%) tirzepatide groups, at week 16 and week 24, respectively, but remained steady in patients receiving placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508107
08HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, body weight fell by 4.2 kg from baseline at week 16 in the tirzepatide 2.5-10.0 mg group.
In plain wordsIn Chinese patients with type 2 diabetes, body weight fell after 16 weeks of tirzepatide.
Peptide
Tirzepatide
Outcome
DecreaseBody weight change in 2.5-10.0 mg group at week 16
Study
n = 10
Outcome group
Body weight · Metabolic and weight
Studied dose
2.5-10.0 mg once weekly · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Body weight reduction from baseline
4.2 kg
tirzepatide 2.5-10.0 mg, week 16
Source sentences
Summary
Body weight decreased from baseline by - 4.2 kg at week 16 in the tirzepatide 2.5-10.0 mg group and by - 6.7 kg at week 24 in the 2.5-15.0 mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508108
09HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, body weight fell by 6.7 kg from baseline at week 24 in the tirzepatide 2.5-15.0 mg group.
In plain wordsIn Chinese patients with type 2 diabetes, body weight fell after 24 weeks of tirzepatide.
Peptide
Tirzepatide
Outcome
DecreaseBody weight change in 2.5-15.0 mg group at week 24
Study
n = 10
Outcome group
Body weight · Metabolic and weight
Studied dose
2.5-15.0 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Body weight reduction from baseline
6.7 kg
tirzepatide 2.5-15.0 mg, week 24
Source sentences
Summary
Body weight decreased from baseline by - 4.2 kg at week 16 in the tirzepatide 2.5-10.0 mg group and by - 6.7 kg at week 24 in the 2.5-15.0 mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508109
10HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, mean fasting plasma glucose fell by 4.6 mmol/L from baseline at week 16 in the tirzepatide 2.5-10.0 mg group.
In plain wordsIn Chinese patients with type 2 diabetes, fasting blood sugar fell after 16 weeks of tirzepatide.
Peptide
Tirzepatide
Outcome
DecreaseFasting plasma glucose change in 2.5-10.0 mg group at week 16
Study
n = 10
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5-10.0 mg once weekly · subcutaneous · 16 weeksAs given in this study (human).
Measurements
Fasting plasma glucose reduction from baseline
4.6 mmol/L
tirzepatide 2.5-10.0 mg, week 16
Source sentences
Summary
Mean fasting plasma glucose levels fell from baseline by - 4.6 mmol/L in the tirzepatide 2.5-10.0 mg group at week 16 and by - 3.7 mmol/L at week 24 in the tirzepatide 2.5-15.0 mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508110
11HumanRandomized controlled trialEfficacy outcome
In Chinese patients with type 2 diabetes, mean fasting plasma glucose fell by 3.7 mmol/L from baseline at week 24 in the tirzepatide 2.5-15.0 mg group.
In plain wordsIn Chinese patients with type 2 diabetes, fasting blood sugar fell after 24 weeks of tirzepatide.
Peptide
Tirzepatide
Outcome
DecreaseFasting plasma glucose change in 2.5-15.0 mg group at week 24
Study
n = 10
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5-15.0 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Fasting plasma glucose reduction from baseline
3.7 mmol/L
tirzepatide 2.5-15.0 mg, week 24
Source sentences
Summary
Mean fasting plasma glucose levels fell from baseline by - 4.6 mmol/L in the tirzepatide 2.5-10.0 mg group at week 16 and by - 3.7 mmol/L at week 24 in the tirzepatide 2.5-15.0 mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo.
Summary · context
The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2).
Report a problemFND-3728508111

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 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1Results postedNCT04235959

A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

Eli Lilly and Companyn = 2421 Oct 2020 to 17 Aug 2021

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 6 Jul 2023

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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Keywords

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