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Study · Randomized controlled trial · n = 76 · 2025

10 results

Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.

Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K

The lancet. Diabetes & endocrinology28 Feb 2025Cited by 27 (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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with obesity disease, more participants reached at least 5% bodyweight reduction at week 72 with tirzepatide 15 mg (96%) than with placebo (20%).

    In plain wordsIn Japanese adults with obesity, far more people lost at least 5% of body weight on tirzepatide 15 mg than on placebo.

    Outcome
    IncreaseProportion with at least 5% bodyweight reduction at week 72
    Study

    n = 76

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

    Measurements

    Responders with at least 5% weight reduction
    96%
    tirzepatide 15 mg
    Responders with at least 5% weight reduction
    20%
    placebo

    Source sentences

    Summary
    At week 72, a higher proportion of participants achieved at least 5% bodyweight reduction with tirzepatide 10 mg (67 [94%] of 71) and 15 mg (73 [96%] of 76) compared with placebo (15 [20%] of 75; both p<0·0001).
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with obesity disease, more participants reached at least 5% bodyweight reduction at week 72 with tirzepatide 10 mg (94%) than with placebo (20%).

    In plain wordsIn Japanese adults with obesity, far more people lost at least 5% of body weight on tirzepatide 10 mg than on placebo.

    Outcome
    IncreaseProportion with at least 5% bodyweight reduction at week 72
    Study

    n = 71

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

    Measurements

    Responders with at least 5% weight reduction
    94%
    tirzepatide 10 mg
    Responders with at least 5% weight reduction
    20%
    placebo

    Source sentences

    Summary
    At week 72, a higher proportion of participants achieved at least 5% bodyweight reduction with tirzepatide 10 mg (67 [94%] of 71) and 15 mg (73 [96%] of 76) compared with placebo (15 [20%] of 75; both p<0·0001).
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with obesity disease without diabetes, tirzepatide 10 mg reduced bodyweight at week 72 by 16.1 percentage points more than placebo.

    In plain wordsIn Japanese adults with obesity, tirzepatide 10 mg led to much more weight loss than placebo over 72 weeks.

    Outcome
    DecreasePercent change in bodyweight at week 72
    Study

    n: not reported in source

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

    Measurements

    Estimated treatment difference vs placebo in bodyweight change
    −16.1%
    tirzepatide 10 mg

    Source sentences

    Summary
    Estimated treatment differences relative to placebo in change in bodyweight at week 72 were -16·1% (95% CI -18·7 to -13·5; p<0·0001) and -21·1% (95% CI -23·6 to -18·5; p<0·0001) following tirzepatide 10 mg and 15 mg, respectively.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with obesity disease without diabetes, tirzepatide 15 mg reduced bodyweight at week 72 by 21.1 percentage points more than placebo.

    In plain wordsIn Japanese adults with obesity, tirzepatide 15 mg led to much more weight loss than placebo over 72 weeks.

    Outcome
    DecreasePercent change in bodyweight at week 72
    Study

    n: not reported in source

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

    Measurements

    Estimated treatment difference vs placebo in bodyweight change
    −21.1%
    tirzepatide 15 mg

    Source sentences

    Summary
    Estimated treatment differences relative to placebo in change in bodyweight at week 72 were -16·1% (95% CI -18·7 to -13·5; p<0·0001) and -21·1% (95% CI -23·6 to -18·5; p<0·0001) following tirzepatide 10 mg and 15 mg, respectively.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with obesity disease, the abstract states that cardiometabolic and body composition indices also improved with tirzepatide, without giving values.

    In plain wordsIn Japanese adults with obesity, tirzepatide also improved heart and metabolic measures and body composition. The abstract gives no values.

    Outcome
    Not applicableCardiometabolic and body composition indices
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Cardiometabolic and body composition indices were also improved with tirzepatide.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese adults with obesity disease, treatment-emergent adverse events were more frequent with tirzepatide 10 mg (84%) than with placebo (69%).

    In plain wordsIn Japanese adults with obesity, side effects of any kind were more common with tirzepatide 10 mg than with placebo.

    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    10 mg · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with treatment-emergent adverse events
    84%
    tirzepatide 10 mg
    Participants with treatment-emergent adverse events
    69%
    placebo

    Source sentences

    Summary
    Participants treated with tirzepatide experienced treatment-emergent adverse events more frequently (10 mg: n=61 [84%]; 15 mg: n=66 [86%]) than those who received placebo (52 [69%]), most commonly gastrointestinal symptoms.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese adults with obesity disease, treatment-emergent adverse events were more frequent with tirzepatide 15 mg (86%) than with placebo (69%).

    In plain wordsIn Japanese adults with obesity, side effects of any kind were more common with tirzepatide 15 mg than with placebo.

    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    15 mg · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Participants with treatment-emergent adverse events
    86%
    tirzepatide 15 mg
    Participants with treatment-emergent adverse events
    69%
    placebo

    Source sentences

    Summary
    Participants treated with tirzepatide experienced treatment-emergent adverse events more frequently (10 mg: n=61 [84%]; 15 mg: n=66 [86%]) than those who received placebo (52 [69%]), most commonly gastrointestinal symptoms.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese adults with obesity disease, the treatment-emergent adverse events with tirzepatide were most commonly gastrointestinal symptoms.

    In plain wordsIn Japanese adults with obesity, the most common side effects of tirzepatide were stomach and gut symptoms.

    Outcome
    Not applicableType of most common adverse events
    Study

    n: not reported in source

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

    Source sentences

    Summary
    most commonly gastrointestinal symptoms.
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese adults with obesity disease, discontinuations due to adverse events were infrequent: 1 participant with tirzepatide 10 mg and 3 with placebo.

    In plain wordsIn Japanese adults with obesity, few people stopped the study because of side effects: 1 on tirzepatide 10 mg and 3 on placebo.

    Outcome
    Direction not reportedStudy discontinuation due to adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    10 mg · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Discontinuations due to adverse events
    1 participants
    tirzepatide 10 mg
    Discontinuations due to adverse events
    3 participants
    placebo

    Source sentences

    Summary
    Study discontinuations due to adverse events were infrequent (placebo: n=3 [4%]; tirzepatide 10 mg: n=1 [1%]; tirzepatide 15 mg: n=0).
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…
  10. 10HumanRandomized controlled trialSafety outcome

    In Japanese adults with obesity disease, discontinuations due to adverse events were infrequent: none with tirzepatide 15 mg and 3 with placebo.

    In plain wordsIn Japanese adults with obesity, few people stopped the study because of side effects: none on tirzepatide 15 mg and 3 on placebo.

    Outcome
    Direction not reportedStudy discontinuation due to adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    15 mg · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Discontinuations due to adverse events
    0 participants
    tirzepatide 15 mg
    Discontinuations due to adverse events
    3 participants
    placebo

    Source sentences

    Summary
    Study discontinuations due to adverse events were infrequent (placebo: n=3 [4%]; tirzepatide 10 mg: n=1 [1%]; tirzepatide 15 mg: n=0).
    1 context sentence
    Summary · context
    Japanese adults with obesity disease (BMI ≥27 kg/m2 accompanied by ≥2 obesity-related health disorders or ≥35 kg/m2 accompanied by ≥1 obesity-related health disorders), excluding diabetes, were assigned 1:1:1 via computer-generated random sequence to receive once weekly subcuta…

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

CompletedPhase 3Results postedNCT04844918

A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

Eli Lilly and Companyn = 26710 May 2021 to 24 Jun 2023

Obesity

Trial pageClinicalTrials.govUpdated 16 Jul 2024

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

    12 Oct 2026, 12:58 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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