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Study · Randomized controlled trial · n = 3,127 · 2025

12 results

Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment.

Wharton S, Aronne LJ, Stefanski A, Alfaris NF, Ciudin A, Yokote K, Halpern B, Shukla AP, Zhou C, Macpherson L, Allen SE, Ahmad NN, Klise SR

The New England journal of medicine16 Sept 2025Cited by 65 (Europe PMC)

PMID40960239 (opens in a new tab)DOI10.1056/nejmoa2511774 (opens in a new tab)PepBankPUB-40960239
Publisher pagePubMedAsk about this study
Jump to 12 results

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron 6 mg reduced body weight by 7.5% versus 2.1% with placebo.

    In plain wordsOrforglipron 6 mg reduced weight by 7.5% versus 2.1% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    6 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −7.5%
    orforglipron 6 mg, baseline to week 72
    95% CI of mean change in body weight
    −8.2 to −6.8%
    orforglipron 6 mg
    Mean change in body weight
    −2.1%
    placebo, baseline to week 72
    95% CI of mean change in body weight
    −2.8 to −1.4%
    placebo
    P value for mean body weight change versus placebo
    < 0.001
    orforglipron 6 mg versus placebo, baseline to week 72

    Source sentences

    Summary
    The mean change in body weight from baseline to week 72 was -7.5% (95% confidence interval [CI], -8.2 to -6.8) with 6 mg of orforglipron,
    3 context sentences
    Summary · context
    as compared with -2.1% (95% CI, -2.8 to -1.4) with placebo (P<0.001 for all comparisons with placebo).
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron 12 mg reduced body weight by 8.4% versus 2.1% with placebo.

    In plain wordsOrforglipron 12 mg reduced weight by 8.4% versus 2.1% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    12 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −8.4%
    orforglipron 12 mg, baseline to week 72
    95% CI of mean change in body weight
    −9.1 to −7.7%
    orforglipron 12 mg
    Mean change in body weight
    −2.1%
    placebo, baseline to week 72
    95% CI of mean change in body weight
    −2.8 to −1.4%
    placebo
    P value for mean body weight change versus placebo
    < 0.001
    orforglipron 12 mg versus placebo, baseline to week 72

    Source sentences

    Summary
    -8.4% (95% CI, -9.1 to -7.7) with 12 mg of orforglipron,
    3 context sentences
    Summary · context
    as compared with -2.1% (95% CI, -2.8 to -1.4) with placebo (P<0.001 for all comparisons with placebo).
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron 36 mg reduced body weight by 11.2% versus 2.1% with placebo.

    In plain wordsOrforglipron 36 mg reduced weight by 11.2% versus 2.1% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    DecreaseBody weight change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    36 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −11.2%
    orforglipron 36 mg, baseline to week 72
    95% CI of mean change in body weight
    −12 to −10.4%
    orforglipron 36 mg
    Mean change in body weight
    −2.1%
    placebo, baseline to week 72
    95% CI of mean change in body weight
    −2.8 to −1.4%
    placebo
    P value for mean body weight change versus placebo
    < 0.001
    orforglipron 36 mg versus placebo, baseline to week 72

    Source sentences

    Summary
    and -11.2% (95% CI, -12.0 to -10.4) with 36 mg of orforglipron, as compared with -2.1% (95% CI, -2.8 to -1.4) with placebo (P<0.001 for all comparisons with placebo).
    2 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron significantly improved waist circumference versus placebo.

    In plain wordsOrforglipron significantly improved waist circumference versus placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    Direction not reportedWaist circumference
    Study

    n = 3,127

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Waist circumference, systolic blood pressure, triglyceride levels, and non-HDL cholesterol levels significantly improved with orforglipron treatment as compared with placebo.
    3 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
    Summary · context
    A total of 3127 patients underwent randomization.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron significantly improved systolic blood pressure versus placebo.

    In plain wordsOrforglipron significantly improved systolic blood pressure versus placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    Direction not reportedSystolic blood pressure
    Study

    n = 3,127

    Comparator
    Placebo
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Waist circumference, systolic blood pressure, triglyceride levels, and non-HDL cholesterol levels significantly improved with orforglipron treatment as compared with placebo.
    3 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
    Summary · context
    A total of 3127 patients underwent randomization.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron significantly improved triglycerides versus placebo.

    In plain wordsOrforglipron significantly improved triglycerides versus placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    Direction not reportedTriglycerides
    Study

    n = 3,127

    Comparator
    Placebo
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Waist circumference, systolic blood pressure, triglyceride levels, and non-HDL cholesterol levels significantly improved with orforglipron treatment as compared with placebo.
    3 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
    Summary · context
    A total of 3127 patients underwent randomization.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, orforglipron significantly improved non-HDL cholesterol versus placebo.

    In plain wordsOrforglipron significantly improved non-HDL cholesterol versus placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    Direction not reportedNon-HDL cholesterol
    Study

    n = 3,127

    Comparator
    Placebo
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Waist circumference, systolic blood pressure, triglyceride levels, and non-HDL cholesterol levels significantly improved with orforglipron treatment as compared with placebo.
    3 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
    Summary · context
    A total of 3127 patients underwent randomization.
  8. 08HumanRandomized controlled trialSafety outcome

    In obesity without diabetes, adverse-event discontinuations occurred in 5.3 to 10.3% with orforglipron versus 2.7% with placebo.

    In plain wordsAdverse-event discontinuations occurred in 5.3 to 10.3% with orforglipron versus 2.7% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    IncreaseAdverse-event discontinuation
    Study

    n = 3,127

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Measurements

    Discontinuation due to adverse events
    5.3 to 10.3%
    orforglipron groups
    Discontinuation due to adverse events
    2.7%
    placebo

    Source sentences

    Summary
    Adverse events resulted in treatment discontinuation in 5.3 to 10.3% of the patients in the orforglipron groups and in 2.7% of those in the placebo group.
    3 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
    Summary · context
    A total of 3127 patients underwent randomization.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, 54.6% achieved at least 10% weight loss with orforglipron 36 mg versus 12.9% with placebo.

    In plain wordsWith orforglipron 36 mg, 54.6% achieved at least 10% weight loss versus 12.9% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    IncreaseWeight loss at least 10%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    36 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Patients with weight reduction of 10% or more
    54.6%
    orforglipron 36 mg
    Patients with weight reduction of 10% or more
    12.9%
    placebo

    Source sentences

    Summary
    Among the patients in the orforglipron 36-mg group, 54.6% had a reduction of 10% or more, 36.0% had a reduction of 15% or more, and 18.4% had a reduction of 20% or more, as compared with 12.9%, 5.9%, and 2.8% of the patients, respectively, in the placebo group.
    2 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, 36.0% achieved at least 15% weight loss with orforglipron 36 mg versus 5.9% with placebo.

    In plain wordsWith orforglipron 36 mg, 36.0% achieved at least 15% weight loss versus 5.9% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    IncreaseWeight loss at least 15%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    36 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Patients with weight reduction of 15% or more
    36%
    orforglipron 36 mg
    Patients with weight reduction of 15% or more
    5.9%
    placebo

    Source sentences

    Summary
    Among the patients in the orforglipron 36-mg group, 54.6% had a reduction of 10% or more, 36.0% had a reduction of 15% or more, and 18.4% had a reduction of 20% or more, as compared with 12.9%, 5.9%, and 2.8% of the patients, respectively, in the placebo group.
    2 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In obesity without diabetes, 18.4% achieved at least 20% weight loss with orforglipron 36 mg versus 2.8% with placebo.

    In plain wordsWith orforglipron 36 mg, 18.4% achieved at least 20% weight loss versus 2.8% with placebo in obesity without diabetes.

    Peptide
    Orforglipron
    Outcome
    IncreaseWeight loss at least 20%
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    36 mg · oral · 72 weeksAs given in this study (human).

    Measurements

    Patients with weight reduction of 20% or more
    18.4%
    orforglipron 36 mg
    Patients with weight reduction of 20% or more
    2.8%
    placebo

    Source sentences

    Summary
    Among the patients in the orforglipron 36-mg group, 54.6% had a reduction of 10% or more, 36.0% had a reduction of 15% or more, and 18.4% had a reduction of 20% or more, as compared with 12.9%, 5.9%, and 2.8% of the patients, respectively, in the placebo group.
    2 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.
  12. 12HumanRandomized controlled trialSafety outcome

    In obesity without diabetes, the most common orforglipron adverse events were gastrointestinal effects, mostly mild to moderate.

    In plain wordsIn obesity without diabetes, the most common orforglipron adverse events were digestive effects, mostly mild to moderate.

    Peptide
    Orforglipron
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events with orforglipron were gastrointestinal effects, which were mostly mild to moderate.
    2 context sentences
    Summary · context
    In this phase 3, multinational, randomized, double-blind trial, we examined the safety and efficacy of once-daily orforglipron at doses of 6 mg, 12 mg, or 36 mg, as compared with placebo (assigned in a 3:3:3:4 ratio) as an adjunct to healthy diet and physical activity for 72 weeks.
    Summary · context
    All the patients had obesity without diabetes mellitus.

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 ongoing · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 3Results postedNCT05869903

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Eli Lilly and Companyn = 3,1275 Jun 2023 to est. Oct 2027

Obesity · Overweight · Overweight or Obesity

Trial pageClinicalTrials.govUpdated 14 Aug 2026

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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