Pharmacokinetic and dose-finding studies on efpeglenatide in patients with type 2 diabetes.

Yoon KH, Kang J, Kwon SC, Trautmann ME, Hompesch M, Stewart J, Sorli CH

Diabetes, obesity & metabolism4 Apr 2020Cited by 25 (Europe PMC)

PMID32175655PMCIDPMC7383501DOI10.1111/dom.14032PepBankPUB-32175655

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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 study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, repeated efpeglenatide doses significantly reduced HbA1c versus placebo.
In plain wordsIn patients with diabetes, repeated efpeglenatide doses reduced HbA1c more than placebo.
Peptide
Efpeglenatide
Outcome
DecreaseHbA1c
Study
n = 71
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1, 2 or 4 mg once weekly or 8, 12 or 16 mg once monthly · subcutaneous · 8 weeks (weekly dosing) or 9 weeks (monthly dosing)As given in this study (human).
Source sentences
Summary
Repeated doses of efpeglenatide led to significant reductions in glycated haemoglobin vs placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Summary · context
Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
Summary · context
The repeated-dose study (n = 71) was a multiple-ascending-dose trial.
Report a problemFND-3217565510
02HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, single-dose efpeglenatide produced dose-proportional serum concentration increases.
In plain wordsIn patients with diabetes, efpeglenatide concentrations increased in proportion to the single dose.
Peptide
Efpeglenatide
Outcome
IncreaseSingle-dose serum concentration proportionality
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2-100 μg/kg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
Both studies demonstrated dose-proportional increases in efpeglenatide serum concentrations.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received a single subcutaneous injection of efpeglenatide (2-100 μg/kg) or placebo.
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565501
03HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, repeated-dose efpeglenatide produced dose-proportional serum concentration increases.
In plain wordsIn patients with diabetes, efpeglenatide concentrations increased in proportion to repeated doses.
Peptide
Efpeglenatide
Outcome
IncreaseRepeated-dose serum concentration proportionality
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1, 2 or 4 mg once weekly or 8, 12 or 16 mg once monthly · subcutaneous · 8 weeks (weekly dosing) or 9 weeks (monthly dosing)As given in this study (human).
Source sentences
Summary
Both studies demonstrated dose-proportional increases in efpeglenatide serum concentrations.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565502
04HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, median time to peak efpeglenatide concentration ranged from 72 to 144 hours after a single dose.
In plain wordsIn patients with diabetes, median time to peak efpeglenatide concentration ranged from 72 to 144 hours after a single dose.
Peptide
Efpeglenatide
Outcome
Not applicableSingle-dose time to peak concentration
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2-100 μg/kg single dose · subcutaneousAs given in this study (human).
Measurements
Median time to peak concentration
72 to 144 hours
single-dose study
Source sentences
Summary
The median time to attain maximum serum concentration (t_max ) for efpeglenatide ranged from 72 to 144 hours in the single-dose study and from 48 to 120 hours in the repeated-dose study (following final dose).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received a single subcutaneous injection of efpeglenatide (2-100 μg/kg) or placebo.
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565503
05HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, median time to peak efpeglenatide concentration ranged from 48 to 120 hours after the final repeated dose.
In plain wordsIn patients with diabetes, median time to peak efpeglenatide concentration ranged from 48 to 120 hours after the final repeated dose.
Peptide
Efpeglenatide
Outcome
Not applicableRepeated-dose time to peak concentration
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1, 2 or 4 mg once weekly or 8, 12 or 16 mg once monthly · subcutaneous · 8 weeks (weekly dosing) or 9 weeks (monthly dosing)As given in this study (human).
Measurements
Median time to peak concentration
48 to 120 hours
final repeated dose
Source sentences
Summary
The median time to attain maximum serum concentration (t_max ) for efpeglenatide ranged from 72 to 144 hours in the single-dose study and from 48 to 120 hours in the repeated-dose study (following final dose).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565504
06HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, efpeglenatide geometric mean half-life ranged from 135 to 180 hours across studies.
In plain wordsIn patients with diabetes, efpeglenatide's geometric mean half-life ranged from 135 to 180 hours.
Peptide
Efpeglenatide
Outcome
Not applicableElimination half-life
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Geometric mean half-life
135 to 180 hours
across studies
Source sentences
Summary
Geometric mean t_1/2 ranged from 135 to 180 hours across studies.
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565505
07HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, repeated weekly efpeglenatide produced peak-to-trough ratios ranging from 1.3 to 1.4.
In plain wordsIn patients with diabetes, weekly efpeglenatide produced peak-to-trough concentration ratios of 1.3 to 1.4.
Peptide
Efpeglenatide
Outcome
Not applicableWeekly peak-to-trough concentration ratio
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1, 2 or 4 mg once weekly · subcutaneous · 8 weeksAs given in this study (human).
Measurements
Peak-to-trough ratio
1.3 to 1.4 ratio
once weekly
Source sentences
Summary
Peak-to-trough ratios in the repeated-dose study ranged from 1.3 to 1.4 with once-weekly dosing and from 5.9 to 12.9 with once-monthly dosing.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565506
08HumanRandomized controlled trialPharmacokinetics
In patients with diabetes, repeated monthly efpeglenatide produced peak-to-trough ratios ranging from 5.9 to 12.9.
In plain wordsIn patients with diabetes, monthly efpeglenatide produced peak-to-trough concentration ratios of 5.9 to 12.9.
Peptide
Efpeglenatide
Outcome
Not applicableMonthly peak-to-trough concentration ratio
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
8, 12 or 16 mg once monthly · subcutaneous · 9 weeksAs given in this study (human).
Measurements
Peak-to-trough ratio
5.9 to 12.9 ratio
once monthly
Source sentences
Summary
Peak-to-trough ratios in the repeated-dose study ranged from 1.3 to 1.4 with once-weekly dosing and from 5.9 to 12.9 with once-monthly dosing.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients received weekly (1, 2 or 4 mg once weekly; 8-week period) or monthly (8, 12 or 16 mg once monthly; 9-week period) subcutaneous injections of efpeglenatide or placebo (without titration).
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565507
09HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, fasting glucose decreased at week 1 after single-dose efpeglenatide and remained below baseline for ≥3 weeks.
In plain wordsIn patients with diabetes, fasting glucose remained below baseline for at least three weeks after single-dose efpeglenatide.
Peptide
Efpeglenatide
Outcome
DecreaseFasting plasma glucose
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14-100 μg/kg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
Following a single dose of efpeglenatide 14-100 μg/kg, fasting plasma glucose and postprandial plasma glucose levels were decreased at week 1 and remained below baseline levels for ≥3 weeks post-dosing.
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565508
10HumanRandomized controlled trialEfficacy outcome
In patients with diabetes, postprandial glucose decreased at week 1 after single-dose efpeglenatide and remained below baseline for ≥3 weeks.
In plain wordsIn patients with diabetes, glucose after meals remained below baseline for at least three weeks after single-dose efpeglenatide.
Peptide
Efpeglenatide
Outcome
DecreasePostprandial plasma glucose
Study
n: not reported in source
Comparator
Baseline
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14-100 μg/kg single dose · subcutaneousAs given in this study (human).
Source sentences
Summary
Following a single dose of efpeglenatide 14-100 μg/kg, fasting plasma glucose and postprandial plasma glucose levels were decreased at week 1 and remained below baseline levels for ≥3 weeks post-dosing.
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565509
11HumanRandomized controlled trialSafety outcome
In patients with diabetes, efpeglenatide was generally well tolerated in both studies.
In plain wordsIn patients with diabetes, efpeglenatide was generally well tolerated in both studies.
Peptide
Efpeglenatide
Outcome
Direction not reportedGeneral tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
In both studies, efpeglenatide was generally well tolerated.
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565511
12HumanRandomized controlled trialSafety outcome
In patients with diabetes, gastrointestinal disorders were the most frequently reported treatment-emergent adverse events with efpeglenatide.
In plain wordsIn patients with diabetes, digestive disorders were the most frequently reported adverse events during efpeglenatide treatment.
Peptide
Efpeglenatide
Outcome
Direction not reportedGastrointestinal disorders
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Gastrointestinal disorders were the most frequently reported treatment-emergent adverse events in efpeglenatide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomized, double-blind, placebo-controlled phase 2 trials were conducted.
Report a problemFND-3217565512

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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

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