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Study · Randomized controlled trial · n = 36 · 2021

8 results

IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study.

Ji L, Jiang H, An P, Deng H, Liu M, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L

EClinicalMedicine13 Aug 2021Cited by 42 (Europe PMC)

PMID34430840 (opens in a new tab)PMCIDPMC8374649 (opens in a new tab)DOI10.1016/j.eclinm.2021.101088 (opens in a new tab)PepBankPUB-34430840
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Summary

BackgroundIBI362 (LY3305677) is a novel weekly-dose glucagon-like peptide-1 and glucagon receptor dual agonist being developed for the treatment of obesity and type 2 diabetes. The aim of this randomised, placebo-controlled, multiple ascending dose phase 1b study was to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI362 in Chinese adults with overweight or obesity.MethodsThis study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China. Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up. The dose-escalation regimens were: 3.0 mg cohort (1.0 mg weeks 1-4; 2.0 mg weeks 5-8; 3.0 mg weeks 9-12); 4.5 mg cohort (1.5 mg weeks 1-4; 3.0 mg weeks 5-8; 4.5 mg weeks 9-12); 6.0 mg cohort (2.0 mg weeks 1-4; 4.0 mg weeks 5-8; 6.0 mg weeks 9-12). The participants, investigators and study site personnel involved in treating and assessing participants within each cohort were masked to treatment allocation. The primary endpoints were safety and tolerability of IBI362. This study is registered with ClinicalTrials.gov, number NCT04440345.FindingsBetween June 15th, 2020 and January 15th, 2021, 12 participants were enrolled and randomised in each cohort. Throughout the study, no participant discontinued the treatment due to safety reason and no serious adverse event was reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events and mostly mild in severity. Three participants receiving IBI362 reported mild and asymptomatic cardiac disorders revealed by electrocardiogram. Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.InterpretationIBI362 was well tolerated and showed a body weight-lowering effect in Chinese adults with overweight or obesity.FundingInnovent Biologics.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Chinese adults with overweight or obesity, no participant discontinued IBI362 treatment for safety reasons.

    In plain wordsIn Chinese adults with overweight or obesity, no one stopped IBI362 (mazdutide) treatment because of safety concerns.

    Peptide
    Mazdutide
    Outcome
    No significant changeDiscontinuation due to safety reasons
    Study

    n = 36

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    no participant discontinued the treatment due to safety reason
    3 context sentences
    Summary · context
    The primary endpoints were safety and tolerability of IBI362.
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  2. 02HumanRandomized controlled trialSafety outcome

    In Chinese adults with overweight or obesity, no serious adverse event was reported with IBI362.

    In plain wordsIn Chinese adults with overweight or obesity, no serious side effects were reported with IBI362 (mazdutide).

    Peptide
    Mazdutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 36

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    no serious adverse event was reported.
    3 context sentences
    Summary · context
    The primary endpoints were safety and tolerability of IBI362.
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  3. 03HumanRandomized controlled trialSafety outcome

    In Chinese adults with overweight or obesity, gastrointestinal adverse events were among the most common adverse events with IBI362 and mostly mild in severity.

    In plain wordsIn Chinese adults with overweight or obesity, stomach and bowel side effects were common with IBI362 (mazdutide) and mostly mild.

    Peptide
    Mazdutide
    Outcome
    Not applicableGastrointestinal adverse events
    Study

    n = 36

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal adverse events and decreased appetite were the most common adverse events and mostly mild in severity.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  4. 04HumanRandomized controlled trialSafety outcome

    In Chinese adults with overweight or obesity, decreased appetite was among the most common adverse events with IBI362 and mostly mild in severity.

    In plain wordsIn Chinese adults with overweight or obesity, decreased appetite was common with IBI362 (mazdutide) and mostly mild.

    Peptide
    Mazdutide
    Outcome
    Not applicableDecreased appetite
    Study

    n = 36

    Outcome group
    Adverse events · Whole body
    Studied dose
    3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Gastrointestinal adverse events and decreased appetite were the most common adverse events and mostly mild in severity.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Chinese adults with overweight or obesity, IBI362 3.0 mg reduced body weight by 4.81% at week 12, compared with a 0.60% increase with placebo.

    In plain wordsIn Chinese adults with overweight or obesity, IBI362 (mazdutide) 3.0 mg lowered body weight, while weight rose slightly with placebo.

    Peptide
    Mazdutide
    Outcome
    DecreaseBody weight percentage change at week 12, 3.0 mg cohort
    Study

    n = 12

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3.0 mg (escalation 1.0 mg, 2.0 mg, 3.0 mg) · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −4.81%
    IBI362 3.0 mg
    Body weight change
    0.6%
    placebo

    Source sentences

    Summary
    Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Chinese adults with overweight or obesity, IBI362 4.5 mg reduced body weight by 6.40% at week 12, compared with a 0.60% increase with placebo.

    In plain wordsIn Chinese adults with overweight or obesity, IBI362 (mazdutide) 4.5 mg lowered body weight, while weight rose slightly with placebo.

    Peptide
    Mazdutide
    Outcome
    DecreaseBody weight percentage change at week 12, 4.5 mg cohort
    Study

    n = 12

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    4.5 mg (escalation 1.5 mg, 3.0 mg, 4.5 mg) · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −6.4%
    IBI362 4.5 mg
    Body weight change
    0.6%
    placebo

    Source sentences

    Summary
    Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Chinese adults with overweight or obesity, IBI362 6.0 mg reduced body weight by 6.05% at week 12, compared with a 0.60% increase with placebo.

    In plain wordsIn Chinese adults with overweight or obesity, IBI362 (mazdutide) 6.0 mg lowered body weight, while weight rose slightly with placebo.

    Peptide
    Mazdutide
    Outcome
    DecreaseBody weight percentage change at week 12, 6.0 mg cohort
    Study

    n = 12

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    6.0 mg (escalation 2.0 mg, 4.0 mg, 6.0 mg) · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Body weight change
    −6.05%
    IBI362 6.0 mg
    Body weight change
    0.6%
    placebo

    Source sentences

    Summary
    Estimated percent changes in mean body weight from baseline to week 12 were -4.81% (95%CI -6.61 to -3.02), -6.40% (-8.23 to -4.58) and -6.05% (-7.91 to -4.18) for participants receiving IBI362 in the 3.0 mg, 4.5 mg and 6.0 mg cohort, respectively, compared with 0.60% (-0.86 to 2.07) for those receiving placebo.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.
  8. 08HumanRandomized controlled trialSafety outcome

    In Chinese adults with overweight or obesity, three participants receiving IBI362 had mild, asymptomatic cardiac disorders on electrocardiogram.

    In plain wordsIn Chinese adults with overweight or obesity, three people on IBI362 (mazdutide) had mild heart tracing changes without symptoms.

    Peptide
    Mazdutide
    Outcome
    Not applicableCardiac disorders on electrocardiogram
    Study

    n: not reported in source

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    3.0 mg, 4.5 mg or 6.0 mg · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Three participants receiving IBI362 reported mild and asymptomatic cardiac disorders revealed by electrocardiogram.
    2 context sentences
    Summary · context
    This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m2) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m2) from six study centres in China.
    Summary · context
    Eligible participants were randomised 2:1 to receive once-weekly subcutaneous injection of IBI362 or placebo in each of the three ascending dose cohorts for 12 weeks with additional 8 weeks of safety follow-up.

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 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1/2NCT04440345

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Innovent Biologics (Suzhou) Co. Ltd.n = 6016 Jun 2020 to 6 Aug 2021

Overweight or Obesity

Trial pageClinicalTrials.govUpdated 28 Nov 2023

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, 18:17 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:47 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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