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Study · Randomized controlled trial · 2026

11 results

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials.

Brændholt Olsen M, Griffin J, Hövelmann U, Macura S, Fredsted Hagen B, Hesse D, Heise T

Diabetes, obesity & metabolism22 Apr 2026Cited by 2 (Europe PMC)

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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In phase 1 participants receiving petrelintide, no serious treatment-emergent adverse events occurred.

    In plain wordsIn phase 1 participants, no serious adverse events emerged during petrelintide treatment.

    Outcome
    Not applicableSerious treatment-emergent adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Petrelintide was well tolerated, with no serious or severe treatment-emergent adverse events (TEAEs).
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  2. 02HumanRandomized controlled trialSafety outcome

    In phase 1 participants receiving petrelintide, no severe treatment-emergent adverse events occurred.

    In plain wordsIn phase 1 participants, no severe adverse events emerged during petrelintide treatment.

    Outcome
    Not applicableSevere treatment-emergent adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Petrelintide was well tolerated, with no serious or severe treatment-emergent adverse events (TEAEs).
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  3. 03HumanRandomized controlled trialSafety outcome

    In phase 1 participants, gastrointestinal disorders were among the most common petrelintide adverse events and were mostly mild.

    In plain wordsIn phase 1 participants, digestive disorders were among the most common petrelintide side effects and were mostly mild.

    Outcome
    Not applicableGastrointestinal disorders
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    In both trials, the most common TEAEs included gastrointestinal (GI) disorders, most of which were mild.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  4. 04HumanRandomized controlled trialSafety outcome

    In phase 1 participants, one participant discontinued petrelintide because of gastrointestinal adverse events.

    In plain wordsOne phase 1 participant stopped petrelintide because of digestive side effects.

    Outcome
    Not applicableDiscontinuation due to gastrointestinal events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Discontinuations due to GI TEAEs
    1 participants
    petrelintide

    Source sentences

    Summary
    One participant discontinued treatment due to GI TEAEs.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  5. 05HumanRandomized controlled trialSafety outcome

    In MAD part 2, nausea occurred in 16.7%-33.3% receiving petrelintide versus 16.7% receiving placebo.

    In plain wordsIn MAD part 2, nausea affected 16.7%-33.3% with petrelintide versus 16.7% with placebo.

    Outcome
    Direction not reportedNausea
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Nausea incidence
    16.7 to 33.3%
    petrelintide
    Nausea incidence
    16.7%
    placebo

    Source sentences

    Summary
    Nausea, the most common GI TEAE, occurred in 16.7%-33.3% of participants receiving petrelintide versus 16.7% for placebo in MAD part 2
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  6. 06HumanRandomized controlled trialSafety outcome

    In phase 1 participants, diarrhoea was rare during petrelintide treatment.

    In plain wordsIn phase 1 participants, diarrhoea was rare during petrelintide treatment.

    Outcome
    Not applicableDiarrhoea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    while diarrhoea was rare and vomiting was only experienced by the participant who discontinued.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  7. 07HumanRandomized controlled trialSafety outcome

    In phase 1 participants, vomiting occurred only in the participant who discontinued petrelintide.

    In plain wordsIn phase 1 participants, only the person who stopped petrelintide experienced vomiting.

    Outcome
    Not applicableVomiting
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    while diarrhoea was rare and vomiting was only experienced by the participant who discontinued.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  8. 08HumanRandomized controlled trialPharmacokinetics

    In phase 1 participants, petrelintide was slowly absorbed.

    In plain wordsIn phase 1 participants, petrelintide entered the bloodstream slowly.

    Outcome
    Not applicableAbsorption
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Petrelintide was slowly absorbed, had a half-life of ~10 days, showed steady-state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  9. 09HumanRandomized controlled trialPharmacokinetics

    In phase 1 participants, petrelintide had a half-life of approximately 10 days.

    In plain wordsIn phase 1 participants, petrelintide had a half-life of approximately 10 days.

    Outcome
    Not applicableHalf-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Half-life
    ≈ 10 days
    petrelintide

    Source sentences

    Summary
    Petrelintide was slowly absorbed, had a half-life of ~10 days, showed steady-state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  10. 10HumanRandomized controlled trialPharmacokinetics

    In phase 1 participants, petrelintide showed steady-state dose proportionality.

    In plain wordsIn phase 1 participants, steady-state petrelintide exposure was proportional to dose.

    Outcome
    Not applicableSteady-state dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Petrelintide was slowly absorbed, had a half-life of ~10 days, showed steady-state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity, petrelintide reduced body weight by up to 8.6% after 16 weeks.

    In plain wordsIn adults with overweight or obesity, weight decreased by up to 8.6% after 16 weeks of petrelintide.

    Outcome
    DecreaseBody weight at 16 weeks
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 16 weeksAs given in this study (human).

    Measurements

    Body weight reduction
    ≤ 8.6%
    16 weeks

    Source sentences

    Summary
    Petrelintide was slowly absorbed, had a half-life of ~10 days, showed steady-state dose proportionality, and reduced body weight by up to 8.6% after 16 weeks.
    2 context sentences
    Summary · context
    Both trials were randomized, placebo-controlled, and double-blind.
    Summary · context
    The SAD and MAD part 1 trials enrolled normal or overweight adults; MAD part 2 enrolled adults with overweight or obesity.

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. 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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