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Study · Randomized controlled trial · n = 92 · 2023

7 results

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1a, blinded, placebo-controlled, randomized, single- and multiple-ascending-dose study in healthy participants.

Pratt E, Ma X, Liu R, Robins D, Haupt A, Coskun T, Sloop KW, Benson C

Diabetes, obesity & metabolism21 Jun 2023Cited by 49 (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-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy participants receiving orforglipron, gastrointestinal tract-related events were the most common adverse events.

    In plain wordsIn healthy participants receiving orforglipron, digestive adverse events were most common.

    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n = 92

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

    Source sentences

    Summary
    The most common adverse events were gastrointestinal tract-related.
    2 context sentences
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy participants, orforglipron pharmacokinetics were approximately dose proportional.

    In plain wordsIn healthy participants, orforglipron exposure was approximately proportional to dose.

    Outcome
    Not applicableDose proportional pharmacokinetics
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Pharmacokinetics were approximately dose proportional,
    2 context sentences
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy participants, mean orforglipron half-life was 24.6 to 35.3 hours after a single dose.

    In plain wordsIn healthy participants, one orforglipron dose had a mean half-life of 24.6 to 35.3 hours.

    Outcome
    Not applicableSingle-dose half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.3-6 mg · oralAs given in this study (human).

    Measurements

    Mean half-life
    24.6 to 35.3 hours
    single dose

    Source sentences

    Summary
    Pharmacokinetics were approximately dose proportional, and the mean t1/2 was 24.6 to 35.3 hours after a single dose (0.3-6 mg).
    2 context sentences
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy participants, mean orforglipron half-life ranged from 48.1 to 67.5 hours on Day 28.

    In plain wordsIn healthy participants, orforglipron had a mean half-life of 48.1 to 67.5 hours on Day 28.

    Outcome
    Not applicableDay 28 half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2-24 mg daily, escalating weekly · oral · 4 weeksAs given in this study (human).

    Measurements

    Mean half-life
    48.1 to 67.5 hours
    Day 28

    Source sentences

    Summary
    On Day 28, the mean t1/2 was 48.1 to 67.5 hours across the dose range (2-24 mg).
    3 context sentences
    Summary · context
    In Part B, participants received 4 weeks of daily repeated oral orforglipron with doses escalating weekly to four different final target doses (2-24 mg).
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In healthy participants, orforglipron reduced weight by up to 5.4 kg after 4 weeks versus 2.4 kg with placebo.

    In plain wordsIn healthy participants, orforglipron reduced weight more than placebo after 4 weeks.

    Outcome
    DecreaseBody weight reduction
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2-24 mg daily, escalating weekly · oral · 4 weeksAs given in this study (human).

    Measurements

    Weight reduction
    ≤ 5.4 kg
    orforglipron
    Weight reduction
    2.4 kg
    placebo
    P value for body weight reduction
    < 0.05 P value
    orforglipron versus placebo, after 4 weeks

    Source sentences

    Summary
    Substantial reductions in body weight of up to 5.4 kg were observed after 4 weeks in orforglipron-treated participants, compared to a reduction of 2.4 kg with placebo (P < 0.05).
    2 context sentences
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In healthy participants, orforglipron decreased fasting glucose across Days 1 to 28.

    In plain wordsIn healthy participants, orforglipron decreased fasting blood glucose across Days 1 to 28.

    Outcome
    DecreaseFasting glucose
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2-24 mg daily, escalating weekly · oral · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Orforglipron decreased fasting glucose levels across Days 1 to 28, and gastric emptying was delayed on Day 28.
    3 context sentences
    Summary · context
    In Part B, participants received 4 weeks of daily repeated oral orforglipron with doses escalating weekly to four different final target doses (2-24 mg).
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.
  7. 07HumanRandomized controlled trialMechanism

    In healthy participants, orforglipron delayed gastric emptying on Day 28.

    In plain wordsIn healthy participants, orforglipron delayed stomach emptying on Day 28.

    Outcome
    DecreaseGastric emptying
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    2-24 mg daily, escalating weekly · oral · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Orforglipron decreased fasting glucose levels across Days 1 to 28, and gastric emptying was delayed on Day 28.
    3 context sentences
    Summary · context
    In Part B, participants received 4 weeks of daily repeated oral orforglipron with doses escalating weekly to four different final target doses (2-24 mg).
    Summary · context
    This was a double-blind, placebo-controlled, Phase 1 study.
    Summary · context
    Overtly healthy adults aged 18 to 65 years with body mass index of 20 to 40 kg/m2 and glycated haemoglobin concentration of 47.5 mmol/mol (<6.5%) were eligible.

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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