Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens.

Frias JP, Nauck MA, Van J, Benson C, Bray R, Cui X, Milicevic Z, Urva S, Haupt A, Robins DA

Diabetes, obesity & metabolism11 Feb 2020Cited by 162 (Europe PMC)

PMID31984598PMCIDPMC7318331DOI10.1111/dom.13979PepBankPUB-31984598

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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, tirzepatide 12 mg lowered HbA1c by 1.7% at week 12, while HbA1c rose by 0.2% with placebo.
In plain wordsIn people with type 2 diabetes, tirzepatide 12 mg lowered HbA1c more than placebo after 12 weeks.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change from baseline at week 12, 12 mg regimen
Study
n = 29
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
12 mg (4 mg weeks 0-3; 8 mg weeks 4-7; 12 mg weeks 8-11) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−1.7%
tirzepatide 12 mg
HbA1c change
0.2%
placebo
Source sentences
Summary
At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks.
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459801
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, tirzepatide 15 mg-1 lowered HbA1c by 2.0% at week 12, while HbA1c rose by 0.2% with placebo.
In plain wordsIn people with type 2 diabetes, tirzepatide 15 mg-1 lowered HbA1c more than placebo after 12 weeks.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change from baseline at week 12, 15 mg-1 regimen
Study
n = 28
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 mg-1 (2.5 mg weeks 0-1; 5 mg weeks 2-3; 10 mg weeks 4-7; 15 mg weeks 8-11) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−2%
tirzepatide 15 mg-1
HbA1c change
0.2%
placebo
Source sentences
Summary
At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks.
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459802
03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, tirzepatide 15 mg-2 lowered HbA1c by 1.8% at week 12, while HbA1c rose by 0.2% with placebo.
In plain wordsIn people with type 2 diabetes, tirzepatide 15 mg-2 lowered HbA1c more than placebo after 12 weeks.
Peptide
Tirzepatide
Outcome
DecreaseHbA1c change from baseline at week 12, 15 mg-2 regimen
Study
n = 28
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
15 mg-2 (2.5 mg weeks 0-3; 7.5 mg weeks 4-7; 15 mg weeks 8-11) · subcutaneous · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−1.8%
tirzepatide 15 mg-2
HbA1c change
0.2%
placebo
Source sentences
Summary
At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks.
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459803
04HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, three patients stopped treatment because of adverse events, one each from the placebo, 12 mg and 15 mg-1 groups.
In plain wordsIn people with type 2 diabetes, three patients stopped treatment because of side effects, one each in the placebo, 12 mg and 15 mg-1 groups.
Peptide
Tirzepatide
Outcome
Direction not reportedDiscontinuation because of adverse events
Study
n = 111
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
12 mg, 15 mg-1 and 15 mg-2 regimens · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Discontinuations due to adverse events
3 patients
all groups
Source sentences
Summary
Three patients discontinued the treatment because of adverse events, one from each of the placebo, 12 mg and 15 mg-1 groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459807
05HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, nausea occurred in 24.1% with tirzepatide 12 mg versus 7.7% with placebo.
In plain wordsIn people with type 2 diabetes, nausea was more common with tirzepatide 12 mg than with placebo.
Peptide
Tirzepatide
Outcome
IncreaseNausea incidence, 12 mg regimen
Study
n = 29
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
12 mg regimen · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Nausea incidence
24.1%
tirzepatide 12 mg
Nausea incidence
7.7%
placebo
Source sentences
Summary
The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg-1 group, 39.3%; 15 mg-2 group, 35.7%.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459804
06HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, nausea occurred in 39.3% with tirzepatide 15 mg-1 versus 7.7% with placebo.
In plain wordsIn people with type 2 diabetes, nausea was more common with tirzepatide 15 mg-1 than with placebo.
Peptide
Tirzepatide
Outcome
IncreaseNausea incidence, 15 mg-1 regimen
Study
n = 28
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 mg-1 regimen · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Nausea incidence
39.3%
tirzepatide 15 mg-1
Nausea incidence
7.7%
placebo
Source sentences
Summary
The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg-1 group, 39.3%; 15 mg-2 group, 35.7%.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459805
07HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, nausea occurred in 35.7% with tirzepatide 15 mg-2 versus 7.7% with placebo.
In plain wordsIn people with type 2 diabetes, nausea was more common with tirzepatide 15 mg-2 than with placebo.
Peptide
Tirzepatide
Outcome
IncreaseNausea incidence, 15 mg-2 regimen
Study
n = 28
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
15 mg-2 regimen · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Nausea incidence
35.7%
tirzepatide 15 mg-2
Nausea incidence
7.7%
placebo
Source sentences
Summary
The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg-1 group, 39.3%; 15 mg-2 group, 35.7%.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo.
Report a problemFND-3198459806

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

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

PepBank is a research reference. Talk to a doctor before you use any peptide.

Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens.

Summary

Results from this study7

Version history

Subjects

Publication types

MeSH terms

Keywords