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Study · Randomized controlled trial · n = 83 · 2026

13 results

A phase 1 single and multiple ascending dose study of orforglipron in Japanese participants with type 2 diabetes.

Ohwaki K, Nakamura C, Nasu R, Takenouchi K, Hirase T

Journal of diabetes investigation1 Dec 2025Cited by 5 (Europe PMC)

PMID41325139 (opens in a new tab)PMCIDPMC12863000 (opens in a new tab)DOI10.1111/jdi.70157 (opens in a new tab)PepBankPUB-41325139
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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 study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese participants with type 2 diabetes, the most common treatment-emergent adverse events with orforglipron were mild gastrointestinal events.

    In plain wordsIn Japanese participants with type 2 diabetes, the most common orforglipron adverse events were mild digestive events.

    Peptide
    Orforglipron
    Outcome
    Direction not reportedGastrointestinal treatment-emergent adverse events
    Study

    n = 83

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Part A: single 2 or 3 mg. Part B: daily multiple ascending doses, final target 12, 24, and 45 mgAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were gastrointestinal events of mild severity.
    2 context sentences
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese participants with type 2 diabetes, no severe or serious adverse events were reported in the orforglipron study.

    In plain wordsIn Japanese participants with type 2 diabetes, no severe or serious adverse events were reported in the orforglipron study.

    Peptide
    Orforglipron
    Outcome
    Not applicableSevere or serious adverse events
    Study

    n = 83

    Outcome group
    Adverse events · Whole body
    Studied dose
    Part A: single 2 or 3 mg. Part B: daily multiple ascending doses, final target 12, 24, and 45 mgAs given in this study (human).

    Source sentences

    Summary
    No severe or serious adverse events were reported.
    2 context sentences
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In Japanese participants with type 2 diabetes, median orforglipron time to maximum concentration at week 12 was 5.92-8.00 h.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron reached maximum concentrations after a median of 5.92-8.00 hours.

    Peptide
    Orforglipron
    Outcome
    Not applicableTime to maximum concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Part B final target doses 12, 24, and 45 mg daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Median tmax
    5.92 to 8 h
    week 12

    Source sentences

    Summary
    At week 12, median tmax was 5.92-8.00 h, and mean terminal half-life was 51.8-76.1 h.
    3 context sentences
    Summary · context
    In Part B, participants received multiple ascending doses of daily oral orforglipron (final target doses: 12, 24, and 45 mg) or placebo for 12 weeks.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In Japanese participants with type 2 diabetes, mean orforglipron terminal half-life at week 12 was 51.8-76.1 h.

    In plain wordsIn Japanese participants with type 2 diabetes, mean orforglipron terminal half-life was 51.8-76.1 hours.

    Peptide
    Orforglipron
    Outcome
    Not applicableTerminal half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Part B final target doses 12, 24, and 45 mg daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Mean terminal half-life
    51.8 to 76.1 h
    week 12

    Source sentences

    Summary
    At week 12, median tmax was 5.92-8.00 h, and mean terminal half-life was 51.8-76.1 h.
    3 context sentences
    Summary · context
    In Part B, participants received multiple ascending doses of daily oral orforglipron (final target doses: 12, 24, and 45 mg) or placebo for 12 weeks.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 12 mg reduced fasting glucose more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 12 mg lowered fasting blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseFasting glucose with 12 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    12 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Fasting glucose change
    −64.8 mg/dL
    12 mg
    Fasting glucose change
    7.4 mg/dL
    placebo

    Source sentences

    Summary
    Following multiple ascending doses, orforglipron groups had greater mean reductions from baseline to week 12 in glycemic parameters (fasting glucose: orforglipron 12 mg -64.8 mg/dL, 24 mg -61.1 mg/dL, 45 mg -65.6 mg/dL, placebo 7.4 mg/dL;
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 24 mg reduced fasting glucose more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 24 mg lowered fasting blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseFasting glucose with 24 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    24 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Fasting glucose change
    −61.1 mg/dL
    24 mg
    Fasting glucose change
    7.4 mg/dL
    placebo

    Source sentences

    Summary
    Following multiple ascending doses, orforglipron groups had greater mean reductions from baseline to week 12 in glycemic parameters (fasting glucose: orforglipron 12 mg -64.8 mg/dL, 24 mg -61.1 mg/dL, 45 mg -65.6 mg/dL, placebo 7.4 mg/dL;
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 45 mg reduced fasting glucose more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 45 mg lowered fasting blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseFasting glucose with 45 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    45 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Fasting glucose change
    −65.6 mg/dL
    45 mg
    Fasting glucose change
    7.4 mg/dL
    placebo

    Source sentences

    Summary
    Following multiple ascending doses, orforglipron groups had greater mean reductions from baseline to week 12 in glycemic parameters (fasting glucose: orforglipron 12 mg -64.8 mg/dL, 24 mg -61.1 mg/dL, 45 mg -65.6 mg/dL, placebo 7.4 mg/dL;
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 12 mg reduced glycated hemoglobin more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 12 mg lowered long-term blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseGlycated hemoglobin with 12 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    12 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Glycated hemoglobin change
    −2.16%
    12 mg
    Glycated hemoglobin change
    0.67%
    placebo

    Source sentences

    Summary
    glycated hemoglobin: orforglipron 12 mg -2.16%, 24 mg -2.17%, 45 mg -2.28%, placebo 0.67%)
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 24 mg reduced glycated hemoglobin more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 24 mg lowered long-term blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseGlycated hemoglobin with 24 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    24 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Glycated hemoglobin change
    −2.17%
    24 mg
    Glycated hemoglobin change
    0.67%
    placebo

    Source sentences

    Summary
    glycated hemoglobin: orforglipron 12 mg -2.16%, 24 mg -2.17%, 45 mg -2.28%, placebo 0.67%)
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 45 mg reduced glycated hemoglobin more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 45 mg lowered long-term blood sugar more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseGlycated hemoglobin with 45 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    45 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Glycated hemoglobin change
    −2.28%
    45 mg
    Glycated hemoglobin change
    0.67%
    placebo

    Source sentences

    Summary
    glycated hemoglobin: orforglipron 12 mg -2.16%, 24 mg -2.17%, 45 mg -2.28%, placebo 0.67%)
    3 context sentences
    Summary · context
    compared with placebo.
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 12 mg reduced body weight more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 12 mg lowered body weight more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight with 12 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    12 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −2.9 kg
    12 mg
    Body weight change
    0.3 kg
    placebo

    Source sentences

    Summary
    and body weight (orforglipron 12 mg -2.9 kg, 24 mg -6.3 kg, 45 mg -4.8 kg, placebo 0.3 kg) compared with placebo.
    2 context sentences
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 24 mg reduced body weight more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 24 mg lowered body weight more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight with 24 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    24 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −6.3 kg
    24 mg
    Body weight change
    0.3 kg
    placebo

    Source sentences

    Summary
    and body weight (orforglipron 12 mg -2.9 kg, 24 mg -6.3 kg, 45 mg -4.8 kg, placebo 0.3 kg) compared with placebo.
    2 context sentences
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In Japanese participants with type 2 diabetes, orforglipron 45 mg reduced body weight more than placebo at week 12.

    In plain wordsIn Japanese participants with type 2 diabetes, orforglipron 45 mg lowered body weight more than placebo.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight with 45 mg
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    45 mg daily target dose · oral · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −4.8 kg
    45 mg
    Body weight change
    0.3 kg
    placebo

    Source sentences

    Summary
    and body weight (orforglipron 12 mg -2.9 kg, 24 mg -6.3 kg, 45 mg -4.8 kg, placebo 0.3 kg) compared with placebo.
    2 context sentences
    Summary · context
    We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.
    Summary · context
    This was a double-blind, placebo-controlled, randomized, phase 1 study.

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.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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