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Study · Randomized controlled trial · n = 36 · 2023

13 results

A randomized Phase I study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 456906, a dual glucagon receptor/glucagon-like peptide-1 receptor agonist, in healthy Japanese men with overweight/obesity.

Yazawa R, Ishida M, Balavarca Y, Hennige AM

Diabetes, obesity & metabolism27 Apr 2023Cited by 20 (Europe PMC)

PMID36974349 (opens in a new tab)DOI10.1111/dom.15064 (opens in a new tab)PepBankPUB-36974349
Publisher pagePubMedAsk about this study
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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 men with overweight or obesity, 10 participants (37.0%) given BI 456906 withdrew from dose escalation due to adverse events, and none given placebo withdrew.

    In plain wordsIn Japanese men with overweight or obesity, some people on BI 456906 stopped dose increases because of side effects. No one on placebo did.

    Peptide
    Survodutide
    Outcome
    IncreaseWithdrawal from dose escalation due to adverse events
    Study

    n = 36

    Comparator
    Placebo
    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Participants withdrawn
    10 participants
    BI 456906
    Proportion withdrawn
    37%
    BI 456906

    Source sentences

    Summary
    Overall, 10 participants (37.0%) treated with BI 456906 withdrew from dose escalation due to adverse events (amylase increase, n = 1; decreased appetite, n = 9), and the proportion of participants was higher in DG 2 (n = 6, 66.7%) versus DGs 1 and 3 (both n = 2, 22.2%). No participants receiving pla…
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  2. 02HumanRandomized controlled trialSafety outcome

    Drug-related adverse events were reported for all participants receiving BI 456906 and for four receiving placebo.

    In plain wordsIn Japanese men with overweight or obesity, every person on BI 456906 had a drug-related side effect, compared with four on placebo.

    Peptide
    Survodutide
    Outcome
    IncreaseDrug-related adverse events
    Study

    n = 36

    Comparator
    Placebo
    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    Drug-related adverse events were reported for all participants receiving BI 456906 and four receiving placebo
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  3. 03HumanRandomized controlled trialSafety outcome

    Decreased appetite was the most frequent drug-related adverse event (n = 24, 66.7%).

    In plain wordsIn Japanese men with overweight or obesity, reduced appetite was the most common drug-related side effect of BI 456906.

    Peptide
    Survodutide
    Outcome
    Not applicableDecreased appetite (drug-related adverse event)
    Study

    n = 36

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Decreased appetite
    24 participants
    all
    Decreased appetite
    66.7%
    all

    Source sentences

    Summary
    the most frequent being decreased appetite (n = 24, 66.7%).
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  4. 04HumanRandomized controlled trialSafety outcome

    Withdrawal from dose escalation due to adverse events was higher in dose group 2 (66.7%) than in dose groups 1 and 3 (22.2% each).

    In plain wordsIn Japanese men on BI 456906, more people in the 4.8 mg weekly group stopped dose increases because of side effects.

    Peptide
    Survodutide
    Outcome
    IncreaseWithdrawal due to adverse events by dose group
    Study

    n = 27

    Comparator
    DG 1 and DG 3
    Outcome group
    Adverse events · Pharmacology
    Studied dose
    4.8 mg once weekly (DG 2 maximum dose) · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Withdrawal proportion
    66.7%
    DG 2
    Withdrawal proportion
    22.2%
    DG 1
    Withdrawal proportion
    22.2%
    DG 3

    Source sentences

    Summary
    Overall, 10 participants (37.0%) treated with BI 456906 withdrew from dose escalation due to adverse events (amylase increase, n = 1; decreased appetite, n = 9), and the proportion of participants was higher in DG 2 (n = 6, 66.7%) versus DGs 1 and 3 (both n = 2, 22.2%).
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese men with overweight or obesity, BI 456906 up to 1.8 mg once weekly decreased placebo-corrected bodyweight by 5.57% after 16 weeks.

    In plain wordsIn Japanese men with overweight or obesity, BI 456906 at up to 1.8 mg weekly lowered body weight more than placebo after 16 weeks.

    Peptide
    Survodutide
    Outcome
    DecreasePlacebo-corrected bodyweight change at 16 weeks, DG 1
    Study

    n = 18

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.8 mg once weekly (DG 1 maximum dose) · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Placebo-corrected bodyweight change
    −5.57%
    DG 1

    Source sentences

    Summary
    Treatment with BI 456906 decreased placebo-corrected bodyweight after 16 weeks (placebo +1.06%): DG 1, -5.57%; DG 2, -12.37%; DG 3, -9.62%.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese men with overweight or obesity, BI 456906 up to 4.8 mg once weekly decreased placebo-corrected bodyweight by 12.37% after 16 weeks.

    In plain wordsIn Japanese men with overweight or obesity, BI 456906 at up to 4.8 mg weekly lowered body weight more than placebo after 16 weeks.

    Peptide
    Survodutide
    Outcome
    DecreasePlacebo-corrected bodyweight change at 16 weeks, DG 2
    Study

    n = 18

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4.8 mg once weekly (DG 2 maximum dose) · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Placebo-corrected bodyweight change
    −12.37%
    DG 2

    Source sentences

    Summary
    Treatment with BI 456906 decreased placebo-corrected bodyweight after 16 weeks (placebo +1.06%): DG 1, -5.57%; DG 2, -12.37%; DG 3, -9.62%.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese men with overweight or obesity, BI 456906 up to 2.4 mg twice weekly decreased placebo-corrected bodyweight by 9.62% after 16 weeks.

    In plain wordsIn Japanese men with overweight or obesity, BI 456906 at up to 2.4 mg twice weekly lowered body weight more than placebo after 16 weeks.

    Peptide
    Survodutide
    Outcome
    DecreasePlacebo-corrected bodyweight change at 16 weeks, DG 3
    Study

    n = 18

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2.4 mg twice weekly (DG 3 maximum dose) · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Placebo-corrected bodyweight change
    −9.62%
    DG 3

    Source sentences

    Summary
    Treatment with BI 456906 decreased placebo-corrected bodyweight after 16 weeks (placebo +1.06%): DG 1, -5.57%; DG 2, -12.37%; DG 3, -9.62%.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  8. 08HumanRandomized controlled trialSafety outcome

    Nine participants given BI 456906 withdrew from dose escalation because of decreased appetite.

    In plain wordsIn Japanese men with overweight or obesity, nine people on BI 456906 stopped dose increases because of reduced appetite.

    Peptide
    Survodutide
    Outcome
    Not applicableWithdrawal due to decreased appetite
    Study

    n: not reported in source

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Withdrawals due to decreased appetite
    9 participants
    BI 456906

    Source sentences

    Summary
    decreased appetite, n = 9
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  9. 09HumanRandomized controlled trialSafety outcome

    One participant given BI 456906 withdrew from dose escalation because of an amylase increase.

    In plain wordsIn Japanese men with overweight or obesity, one person on BI 456906 stopped dose increases because of a rise in amylase.

    Peptide
    Survodutide
    Outcome
    Not applicableWithdrawal due to amylase increase
    Study

    n: not reported in source

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Withdrawals due to amylase increase
    1 participants
    BI 456906

    Source sentences

    Summary
    amylase increase, n = 1
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  10. 10HumanRandomized controlled trialPharmacokinetics

    BI 456906 exposure increased with dose and with dose escalation in each dose group.

    In plain wordsIn Japanese men with overweight or obesity, blood levels of BI 456906 rose with higher doses.

    Peptide
    Survodutide
    Outcome
    IncreaseBI 456906 exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    BI 456906 exposure increased with dose and dose escalation in each DG.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  11. 11HumanRandomized controlled trialMechanism

    Paracetamol absorption decreased in Week 1 for dose groups 2 and 3 given BI 456906, which indicates transient delayed gastric emptying.

    In plain wordsIn Japanese men on BI 456906, paracetamol absorption fell in the first week at two dose levels, which points to briefly slower stomach emptying.

    Peptide
    Survodutide
    Outcome
    DecreaseParacetamol absorption (gastric emptying) in Week 1
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    DG 2 and DG 3 · subcutaneous · 1 weekAs given in this study (human).

    Source sentences

    Summary
    Paracetamol absorption decreased in Week 1 for DGs 2 and 3, indicating transient delayed gastric emptying.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  12. 12HumanRandomized controlled trialMechanism

    BI 456906 reduced plasma alanine levels, which indicates indirect target engagement at GCGRs and GLP-1Rs.

    In plain wordsIn Japanese men, BI 456906 lowered blood alanine, which suggests the drug acts on its target receptors.

    Peptide
    Survodutide
    Outcome
    DecreasePlasma alanine
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    BI 456906 reduced plasma alanine and glucagon levels, indicating indirect target engagement at GCGRs and GLP-1Rs.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .
  13. 13HumanRandomized controlled trialMechanism

    BI 456906 reduced plasma glucagon levels, which indicates indirect target engagement at GCGRs and GLP-1Rs.

    In plain wordsIn Japanese men, BI 456906 lowered blood glucagon, which suggests the drug acts on its target receptors.

    Peptide
    Survodutide
    Outcome
    DecreasePlasma glucagon
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Receptor activity and mechanism · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    BI 456906 reduced plasma alanine and glucagon levels, indicating indirect target engagement at GCGRs and GLP-1Rs.
    2 context sentences
    Summary · context
    To report a Phase I study of subcutaneous glucagon receptor (GCGR)/glucagon-like peptide-1 receptor (GLP-1R) dual agonist BI 456906 versus placebo in healthy Japanese men with overweight/obesity.
    Summary · context
    We investigated multiple rising doses of BI 456906 escalated over 16 weeks (maximum doses: 1.8 mg once weekly [dose group {DG} 1], 4.8 mg once weekly [DG 2] and 2.4 mg twice weekly [DG 3]) in Japanese men with a body mass index of 23 to 40 kg/m2 .

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

    9 Oct 2026, 19:08 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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