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Study · Randomized controlled trial · n = 44 · 2018

10 results

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S

Advances in therapy13 Mar 2018Cited by 25 (Europe PMC)

PMID29536338 (opens in a new tab)PMCIDPMC5910468 (opens in a new tab)DOI10.1007/s12325-018-0677-1 (opens in a new tab)PepBankPUB-29536338
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Summary

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

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy men, steady-state semaglutide AUC0-168h was similar in Japanese and Caucasian subjects at 0.5 mg and 1.0 mg.

    In plain wordsIn healthy men, the amount of semaglutide in the blood at steady state was similar in Japanese and Caucasian men.

    Peptide
    Semaglutide
    Outcome
    No significant changeSteady-state AUC0-168h, Japanese versus Caucasian
    Study

    n: not reported in source

    Comparator
    Caucasian subjects
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    AUC0-168h estimated race ratio
    1.06 ratio
    0.5 mg
    AUC0-168h estimated race ratio
    0.99 ratio
    1.0 mg

    Source sentences

    Summary
    Steady-state exposure of semaglutide was similar for both populations: AUC0-168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (Cmax) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  2. 02HumanRandomized controlled trialSafety outcome

    No new safety issues were identified with semaglutide in healthy Japanese and Caucasian men.

    In plain wordsNo new safety problems appeared with semaglutide in healthy Japanese and Caucasian men.

    Peptide
    Semaglutide
    Outcome
    Not applicableSafety in healthy Japanese and Caucasian men
    Study

    n = 44

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    No new safety issues were identified.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In healthy Japanese men, semaglutide 0.5 mg and 1.0 mg reduced body weight significantly versus placebo.

    In plain wordsIn healthy Japanese men, semaglutide lowered body weight more than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change in Japanese subjects
    Study

    n = 22

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In healthy Caucasian men, semaglutide 0.5 mg and 1.0 mg reduced body weight significantly versus placebo.

    In plain wordsIn healthy Caucasian men, semaglutide lowered body weight more than placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change in Caucasian subjects
    Study

    n = 22

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy men, steady-state semaglutide Cmax was similar in Japanese and Caucasian subjects at 0.5 mg and 1.0 mg.

    In plain wordsIn healthy men, the peak semaglutide level at steady state was similar in Japanese and Caucasian men.

    Peptide
    Semaglutide
    Outcome
    No significant changeSteady-state Cmax, Japanese versus Caucasian
    Study

    n: not reported in source

    Comparator
    Caucasian subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    Cmax estimated race ratio
    1.06 ratio
    0.5 mg
    Cmax estimated race ratio
    1.02 ratio
    1.0 mg

    Source sentences

    Summary
    Steady-state exposure of semaglutide was similar for both populations: AUC0-168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (Cmax) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  6. 06HumanRandomized controlled trialPharmacokinetics

    After the first 0.25 mg dose, semaglutide AUC0-168h was slightly higher in Japanese than in Caucasian healthy men.

    In plain wordsAfter the first dose, Japanese men had slightly more semaglutide in the blood than Caucasian men.

    Peptide
    Semaglutide
    Outcome
    IncreaseAUC0-168h after the first 0.25 mg dose, Japanese versus Caucasian
    Study

    n: not reported in source

    Comparator
    Caucasian subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.25 mg · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    AUC0-168h estimated race ratio
    1.11 ratio
    first dose 0.25 mg

    Source sentences

    Summary
    Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC0-168h ERR 1.11; Cmax ERR 1.14).
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  7. 07HumanRandomized controlled trialPharmacokinetics

    After the first 0.25 mg dose, semaglutide Cmax was slightly higher in Japanese than in Caucasian healthy men.

    In plain wordsAfter the first dose, Japanese men had a slightly higher peak semaglutide level than Caucasian men.

    Peptide
    Semaglutide
    Outcome
    IncreaseCmax after the first 0.25 mg dose, Japanese versus Caucasian
    Study

    n: not reported in source

    Comparator
    Caucasian subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.25 mg · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    Cmax estimated race ratio
    1.14 ratio
    first dose 0.25 mg

    Source sentences

    Summary
    Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC0-168h ERR 1.11; Cmax ERR 1.14).
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  8. 08HumanRandomized controlled trialPharmacokinetics

    Semaglutide AUC0-168h increased with dose in both Japanese and Caucasian healthy men.

    In plain wordsIn healthy men of both groups, a higher semaglutide dose gave more semaglutide in the blood.

    Peptide
    Semaglutide
    Outcome
    IncreaseDose-dependence of AUC0-168h
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    Dose-dependent increases in AUC0-168h and Cmax occurred in both populations.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  9. 09HumanRandomized controlled trialPharmacokinetics

    Semaglutide Cmax increased with dose in both Japanese and Caucasian healthy men.

    In plain wordsIn healthy men of both groups, a higher semaglutide dose gave a higher peak level.

    Peptide
    Semaglutide
    Outcome
    IncreaseDose-dependence of Cmax
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Source sentences

    Summary
    Dose-dependent increases in AUC0-168h and Cmax occurred in both populations.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).
  10. 10HumanRandomized controlled trialPharmacokinetics

    Semaglutide accumulation was as expected from its half-life of about 1 week and its weekly dosing interval.

    In plain wordsSemaglutide built up in the body as expected from its half-life of about one week and weekly dosing.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide half-life and accumulation
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg and 1.0 mg · subcutaneous · 13 weeksAs given in this study (human).

    Measurements

    Half-life
    ≈ 1 week
    semaglutide

    Source sentences

    Summary
    Accumulation was as expected, based on the half-life (t1/2, ~ 1 week) and dosing interval of semaglutide.
    1 context sentence
    Summary · context
    In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3).

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02146079

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Novo Nordisk A/Sn = 4421 May 2014 to 20 Oct 2014

Diabetes · Diabetes Mellitus, Type 2 · Healthy

Trial pageClinicalTrials.govUpdated 18 Apr 2018

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.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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