Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial.

Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S

Diabetes care1 Jul 2022Cited by 32 (Europe PMC)

PMID35671039PMCIDPMC9274225DOI10.2337/dc21-2656PepBankPUB-35671039

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

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

01HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, efpeglenatide 2 mg produced a statistically superior HbA1c reduction from baseline versus placebo at week 30 (least squares mean -0.5%; P=0.0054).
In plain wordsIn adults with diabetes, efpeglenatide 2 mg reduced HbA1c more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2 mg once weekly · 30 weeksAs given in this study (human).
Measurements
Least squares mean HbA1c reduction
−0.5%
2 mg versus placebo, week 30
Least squares mean HbA1c reduction 95% CI
−0.9 to −0.2%
2 mg versus placebo, week 30
HbA1c at week 30
6.9%
2 mg (baseline 8.1%)
Source sentences
Summary
Least squares mean HbA1c reductions from baseline were statistically superior for each efpeglenatide dose versus placebo (2 mg, -0.5% [95% CI -0.9, -0.2; P = 0.0054]; 4 mg, -0.8% [-1.2, -0.5; P < 0.0001]; 6 mg, -1.0% [-1.4, -0.7; P < 0.0001]).
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, HbA1c was reduced from a baseline of 8.1% (65 mmol/mol) to 6.9% (52 mmol/mol), 6.6% (49 mmol/mol), and 6.4% (47 mmol/mol) with efpeglenatide 2, 4, and 6 mg, respectively.
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103901
02HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, efpeglenatide 4 mg produced a statistically superior HbA1c reduction from baseline versus placebo at week 30 (least squares mean -0.8%; P<0.0001).
In plain wordsIn adults with diabetes, efpeglenatide 4 mg reduced HbA1c more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4 mg once weekly · 30 weeksAs given in this study (human).
Measurements
Least squares mean HbA1c reduction
−0.8%
4 mg versus placebo, week 30
Least squares mean HbA1c reduction 95% CI
−1.2 to −0.5%
4 mg versus placebo, week 30
HbA1c at week 30
6.6%
4 mg (baseline 8.1%)
Source sentences
Summary
Least squares mean HbA1c reductions from baseline were statistically superior for each efpeglenatide dose versus placebo (2 mg, -0.5% [95% CI -0.9, -0.2; P = 0.0054]; 4 mg, -0.8% [-1.2, -0.5; P < 0.0001]; 6 mg, -1.0% [-1.4, -0.7; P < 0.0001]).
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, HbA1c was reduced from a baseline of 8.1% (65 mmol/mol) to 6.9% (52 mmol/mol), 6.6% (49 mmol/mol), and 6.4% (47 mmol/mol) with efpeglenatide 2, 4, and 6 mg, respectively.
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103902
03HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, efpeglenatide 6 mg produced a statistically superior HbA1c reduction from baseline versus placebo at week 30 (least squares mean -1.0%; P<0.0001).
In plain wordsIn adults with diabetes, efpeglenatide 6 mg reduced HbA1c more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
6 mg once weekly · 30 weeksAs given in this study (human).
Measurements
Least squares mean HbA1c reduction
−1%
6 mg versus placebo, week 30
Least squares mean HbA1c reduction 95% CI
−1.4 to −0.7%
6 mg versus placebo, week 30
HbA1c at week 30
6.4%
6 mg (baseline 8.1%)
Source sentences
Summary
Least squares mean HbA1c reductions from baseline were statistically superior for each efpeglenatide dose versus placebo (2 mg, -0.5% [95% CI -0.9, -0.2; P = 0.0054]; 4 mg, -0.8% [-1.2, -0.5; P < 0.0001]; 6 mg, -1.0% [-1.4, -0.7; P < 0.0001]).
2 context sentences(design, population, supporting numbers)
Summary · context
At week 30, HbA1c was reduced from a baseline of 8.1% (65 mmol/mol) to 6.9% (52 mmol/mol), 6.6% (49 mmol/mol), and 6.4% (47 mmol/mol) with efpeglenatide 2, 4, and 6 mg, respectively.
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103903
04HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, efpeglenatide 4 and 6 mg significantly reduced body weight versus placebo at week 30 (P<0.05).
In plain wordsIn adults with diabetes, efpeglenatide 4 and 6 mg reduced weight more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseBody weight
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
4 and 6 mg once weekly · 30 weeksAs given in this study (human).
Source sentences
Summary
A greater proportion of efpeglenatide-treated patients (all doses) achieved HbA1c <7% (53 mmol/mol) versus placebo by week 30 (P < 0.0001 for all), and significant reductions in body weight and fasting plasma glucose were also observed for efpeglenatide (4 and 6 mg doses) versus placebo at week 30 (P < 0.05 for all).
1 context sentence(design, population, supporting numbers)
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103905
05HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, efpeglenatide 4 and 6 mg significantly reduced fasting plasma glucose versus placebo at week 30 (P<0.05).
In plain wordsIn adults with diabetes, efpeglenatide 4 and 6 mg reduced fasting glucose more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseFasting plasma glucose
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
4 and 6 mg once weekly · 30 weeksAs given in this study (human).
Source sentences
Summary
A greater proportion of efpeglenatide-treated patients (all doses) achieved HbA1c <7% (53 mmol/mol) versus placebo by week 30 (P < 0.0001 for all), and significant reductions in body weight and fasting plasma glucose were also observed for efpeglenatide (4 and 6 mg doses) versus placebo at week 30 (P < 0.05 for all).
1 context sentence(design, population, supporting numbers)
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103906
06HumanRandomized controlled trialEfficacy outcome
In adults with diabetes, a greater proportion of patients on any efpeglenatide dose reached HbA1c below 7% versus placebo by week 30 (P<0.0001 for all).
In plain wordsIn adults with diabetes, more efpeglenatide recipients reached HbA1c below 7% than placebo recipients.
Peptide
Efpeglenatide
Outcome
IncreaseHbA1c below 7%
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2, 4 and 6 mg once weekly · 30 weeksAs given in this study (human).
Source sentences
Summary
A greater proportion of efpeglenatide-treated patients (all doses) achieved HbA1c <7% (53 mmol/mol) versus placebo by week 30 (P < 0.0001 for all), and significant reductions in body weight and fasting plasma glucose were also observed for efpeglenatide (4 and 6 mg doses) versus placebo at week 30 (P < 0.05 for all).
1 context sentence(design, population, supporting numbers)
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103904
07HumanRandomized controlled trialSafety outcome
In adults with diabetes, gastrointestinal adverse events were most common with efpeglenatide and generally transient and mild or moderate.
In plain wordsIn adults with diabetes, digestive adverse events were most common with efpeglenatide and generally temporary and mild or moderate.
Peptide
Efpeglenatide
Outcome
Direction not reportedGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Consistent with the GLP-1 RA class, gastrointestinal adverse events were most commonly reported; these were generally transient and mild/moderate in severity.
1 context sentence(design, population, supporting numbers)
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103907
08HumanRandomized controlled trialSafety outcome
In adults with diabetes receiving efpeglenatide, few patients reported hypoglycemia.
In plain wordsIn adults with diabetes receiving efpeglenatide, few patients reported low blood sugar.
Peptide
Efpeglenatide
Outcome
Direction not reportedHypoglycemia
Study
n: not reported in source
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated
Source sentences
Summary
Few patients reported hypoglycemia.
1 context sentence(design, population, supporting numbers)
Summary · context
AMPLITUDE-M was a phase 3, double-blind, placebo-controlled, multicenter trial that randomized adults with type 2 diabetes suboptimally controlled with diet and exercise alone to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks.
Report a problemFND-3567103908

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
27 Oct 2026, 18:20 UTC
Study results updated
Version 1
27 Oct 2026, 16:32 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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