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Study · Randomized controlled trial · n = 443 · 2022

17 results

Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.

Kadowaki T, Chin R, Ozeki A, Imaoka T, Ogawa Y

The lancet. Diabetes & endocrinology30 Jul 2022Cited by 101 (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 study17

17 results from studies that gave the peptide. 17 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes on oral monotherapy, most participants had at least one treatment-emergent adverse event with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, most people taking tirzepatide had at least one side effect during treatment.

    Outcome
    Not applicableAny treatment-emergent adverse event
    Study

    n = 443

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with at least one TEAE
    343 participants
    tirzepatide, all doses

    Source sentences

    Summary
    Most participants (343 [77%] of 443) had at least one treatment-emergent adverse event.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  2. 02HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, treatment-emergent adverse events occurred in 109 of 148 participants on tirzepatide 5 mg.

    In plain wordsIn Japanese adults with type 2 diabetes, 109 of 148 people on tirzepatide 5 mg had a side effect during treatment.

    Outcome
    Not applicableTreatment-emergent adverse events, 5 mg
    Study

    n = 148

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    5 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with TEAE
    109 participants
    5 mg

    Source sentences

    Summary
    Treatment-emergent adverse events were more frequent in the tirzepatide 15 mg group (125 [84%] of 148) than the 5 mg (109 [74%] of 148) and 10 mg groups (109 [74%] of 147).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  3. 03HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, treatment-emergent adverse events were more frequent with tirzepatide 15 mg than with 5 mg and 10 mg.

    In plain wordsIn Japanese adults with type 2 diabetes, side effects were more common on tirzepatide 15 mg than on 5 mg or 10 mg.

    Outcome
    IncreaseTreatment-emergent adverse events, 15 mg
    Study

    n = 148

    Comparator
    Tirzepatide 5 mg and 10 mg
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with TEAE
    125 participants
    15 mg

    Source sentences

    Summary
    Treatment-emergent adverse events were more frequent in the tirzepatide 15 mg group (125 [84%] of 148) than the 5 mg (109 [74%] of 148) and 10 mg groups (109 [74%] of 147).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  4. 04HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, treatment-emergent adverse events occurred in 109 of 147 participants on tirzepatide 10 mg.

    In plain wordsIn Japanese adults with type 2 diabetes, 109 of 147 people on tirzepatide 10 mg had a side effect during treatment.

    Outcome
    Not applicableTreatment-emergent adverse events, 10 mg
    Study

    n = 147

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    10 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with TEAE
    109 participants
    10 mg

    Source sentences

    Summary
    Treatment-emergent adverse events were more frequent in the tirzepatide 15 mg group (125 [84%] of 148) than the 5 mg (109 [74%] of 148) and 10 mg groups (109 [74%] of 147).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  5. 05HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, mild or moderate nasopharyngitis was among the most frequent adverse events with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, mild or moderate nasopharyngitis was a common side effect of tirzepatide.

    Outcome
    Not applicableNasopharyngitis
    Study

    n = 443

    Outcome group
    Adverse events · Infection
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with nasopharyngitis
    75 participants
    tirzepatide, all doses

    Source sentences

    Summary
    The most frequent treatment-emergent adverse events with tirzepatide were mild or moderate nasopharyngitis (75 [17%]), nausea (74 [17%]), constipation (54 [12%]), diarrhoea (51 [12%]), and decreased appetite (44 [10%]).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  6. 06HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, mild or moderate nausea was among the most frequent adverse events with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, mild or moderate nausea was a common side effect of tirzepatide.

    Outcome
    Not applicableNausea
    Study

    n = 443

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with nausea
    74 participants
    tirzepatide, all doses

    Source sentences

    Summary
    The most frequent treatment-emergent adverse events with tirzepatide were mild or moderate nasopharyngitis (75 [17%]), nausea (74 [17%]), constipation (54 [12%]), diarrhoea (51 [12%]), and decreased appetite (44 [10%]).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  7. 07HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, mild or moderate constipation was among the most frequent adverse events with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, mild or moderate constipation was a common side effect of tirzepatide.

    Outcome
    Not applicableConstipation
    Study

    n = 443

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with constipation
    54 participants
    tirzepatide, all doses

    Source sentences

    Summary
    The most frequent treatment-emergent adverse events with tirzepatide were mild or moderate nasopharyngitis (75 [17%]), nausea (74 [17%]), constipation (54 [12%]), diarrhoea (51 [12%]), and decreased appetite (44 [10%]).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  8. 08HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, mild or moderate diarrhoea was among the most frequent adverse events with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, mild or moderate diarrhoea was a common side effect of tirzepatide.

    Outcome
    Not applicableDiarrhoea
    Study

    n = 443

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with diarrhoea
    51 participants
    tirzepatide, all doses

    Source sentences

    Summary
    The most frequent treatment-emergent adverse events with tirzepatide were mild or moderate nasopharyngitis (75 [17%]), nausea (74 [17%]), constipation (54 [12%]), diarrhoea (51 [12%]), and decreased appetite (44 [10%]).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  9. 09HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, mild or moderate decreased appetite was among the most frequent adverse events with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, mild or moderate loss of appetite was a common side effect of tirzepatide.

    Outcome
    Not applicableDecreased appetite
    Study

    n = 443

    Outcome group
    Appetite and food intake · Gastrointestinal
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants with decreased appetite
    44 participants
    tirzepatide, all doses

    Source sentences

    Summary
    The most frequent treatment-emergent adverse events with tirzepatide were mild or moderate nasopharyngitis (75 [17%]), nausea (74 [17%]), constipation (54 [12%]), diarrhoea (51 [12%]), and decreased appetite (44 [10%]).
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  10. 10HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, 398 of 443 participants (90%) completed the study and treatment with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, 398 of 443 people (90%) finished the study and treatment with tirzepatide.

    Outcome
    Not applicableStudy completion
    Study

    n = 443

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Participants completing study and treatment
    398 participants
    tirzepatide, all doses

    Source sentences

    Summary
    398 (90%) participants completed the study and treatment.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  11. 11HumanRandomized controlled trialSafety outcome

    In Japanese adults with type 2 diabetes, no adjudication-confirmed deaths were reported with tirzepatide.

    In plain wordsIn Japanese adults with type 2 diabetes, no deaths confirmed by adjudication were reported during tirzepatide treatment.

    Outcome
    No significant changeDeaths
    Study

    n = 443

    Outcome group
    Mortality · Whole body
    Studied dose
    5, 10 or 15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    No adjudication-confirmed deaths were reported.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  12. 12HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, body weight fell from baseline with tirzepatide 5 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 5 mg reduced body weight from baseline after 52 weeks.

    Outcome
    DecreaseBody weight change at week 52, 5 mg
    Study

    n = 148

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −3.8 kg
    5 mg
    Mean change in body weight
    −5.1%
    5 mg

    Source sentences

    Summary
    At week 52, mean changes from baseline in bodyweight were -3·8 kg (SE 0·5; -5·1% reduction) in the 5 mg group, -7·5 kg (0·5; -10·1% reduction) in the 10 mg group, and -10·2 kg (0·5; -13·2% reduction) in the 15 mg group.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  13. 13HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, body weight fell from baseline with tirzepatide 15 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 15 mg reduced body weight from baseline after 52 weeks.

    Outcome
    DecreaseBody weight change at week 52, 15 mg
    Study

    n = 148

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −10.2 kg
    15 mg
    Mean change in body weight
    −13.2%
    15 mg

    Source sentences

    Summary
    At week 52, mean changes from baseline in bodyweight were -3·8 kg (SE 0·5; -5·1% reduction) in the 5 mg group, -7·5 kg (0·5; -10·1% reduction) in the 10 mg group, and -10·2 kg (0·5; -13·2% reduction) in the 15 mg group.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  14. 14HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, HbA1c fell from baseline with tirzepatide 5 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 5 mg lowered HbA1c from baseline after 52 weeks.

    Outcome
    DecreaseHbA1c at week 52, 5 mg
    Study

    n = 148

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    LS mean HbA1c baseline
    8.5%
    5 mg
    LS mean HbA1c week 52
    6%
    5 mg

    Source sentences

    Summary
    Least squares mean HbA1c at baseline reduced from 8·5% (SE 0·1) to 6·0% (0·1) in the 5 mg tirzepatide group, from 8·6% (0·1) to 5·6% (0·1) in the 10 mg group, and from 8·6% (0·1) to 5·6% (0·1) in the 15 mg group at week 52.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  15. 15HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, HbA1c fell from baseline with tirzepatide 15 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 15 mg lowered HbA1c from baseline after 52 weeks.

    Outcome
    DecreaseHbA1c at week 52, 15 mg
    Study

    n = 148

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    15 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    LS mean HbA1c baseline
    8.6%
    15 mg
    LS mean HbA1c week 52
    5.6%
    15 mg

    Source sentences

    Summary
    Least squares mean HbA1c at baseline reduced from 8·5% (SE 0·1) to 6·0% (0·1) in the 5 mg tirzepatide group, from 8·6% (0·1) to 5·6% (0·1) in the 10 mg group, and from 8·6% (0·1) to 5·6% (0·1) in the 15 mg group at week 52.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  16. 16HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, body weight fell from baseline with tirzepatide 10 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 10 mg reduced body weight from baseline after 52 weeks.

    Outcome
    DecreaseBody weight change at week 52, 10 mg
    Study

    n = 147

    Comparator
    Baseline
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    10 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Mean change in body weight
    −7.5 kg
    10 mg
    Mean change in body weight
    −10.1%
    10 mg

    Source sentences

    Summary
    At week 52, mean changes from baseline in bodyweight were -3·8 kg (SE 0·5; -5·1% reduction) in the 5 mg group, -7·5 kg (0·5; -10·1% reduction) in the 10 mg group, and -10·2 kg (0·5; -13·2% reduction) in the 15 mg group.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…
  17. 17HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with type 2 diabetes, HbA1c fell from baseline with tirzepatide 10 mg at week 52.

    In plain wordsIn Japanese adults with type 2 diabetes, tirzepatide 10 mg lowered HbA1c from baseline after 52 weeks.

    Outcome
    DecreaseHbA1c at week 52, 10 mg
    Study

    n = 147

    Comparator
    Baseline
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10 mg · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    LS mean HbA1c baseline
    8.6%
    10 mg
    LS mean HbA1c week 52
    5.6%
    10 mg

    Source sentences

    Summary
    Least squares mean HbA1c at baseline reduced from 8·5% (SE 0·1) to 6·0% (0·1) in the 5 mg tirzepatide group, from 8·6% (0·1) to 5·6% (0·1) in the 10 mg group, and from 8·6% (0·1) to 5·6% (0·1) in the 15 mg group at week 52.
    2 context sentences
    Summary · context
    This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.
    Summary · context
    After a 2-week screening and 2-week lead-in period, all participants were randomly assigned (1:1:1) to receive 5, 10, or 15 mg of tirzepatide, administered once per week subcutaneously for 52 weeks followed by a 4 week safety follow-up period, using a computer-generated random sequence and interacti…

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 postedNCT03861039

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Eli Lilly and Companyn = 44330 Mar 2019 to 16 Feb 2021

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 14 Feb 2022

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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