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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURMOUNT-J

NCTNCT04844918 (opens ClinicalTrials.gov in a new tab)Other id17506Other idI8F-JE-GPHZ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
267 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
10 May 2021
Primary completion
24 Jun 2023
Completion
24 Jun 2023
First posted
14 Apr 2021
Last update posted
16 Jul 2024
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    SURMOUNT-J

    NCT04844918

    10 May 2021 to 24 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

Interventions

  • TirzepatideDrug
  • PlaceboOther

Arms3

  • Experimental

    10 Milligrams (mg) Tirzepatide

    Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).

  • Experimental

    15 mg Tirzepatide

    Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.

  • Placebo comparator

    Placebo

    Participants received matching placebo administered SC QW.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Mean Percent Change in Body Weight

    Time frame · Baseline, 72 Weeks

    Registry description

    Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Secondary outcomes(20)

  1. Percentage of Participants Who Had Improvement in Obesity-related Health Problems

    Time frame · Week 72

    Registry description

    Percentage of participants who had improvement in obesity-related health problems

  2. Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  3. Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  4. Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

    Time frame · Baseline, Week 72

    Registry description

    Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  5. Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

    Time frame · Baseline, Week 72

    Registry description

    Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI.

  6. Percentage of Participants Who Achieved Improvements of IGT

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.

  7. Percentage of Participants Who Achieved Improvements of Hyperlipidemia

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.

  8. Percentage of Participants Who Achieved Improvements of NAFLD

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.

  9. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieve ≥10% body weight reduction.

  10. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieve ≥15% body weight reduction.

  11. Change From Baseline in Absolute Body Weight

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  12. Change From Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  13. Percent Change From Baseline in Visceral Adipose Tissue (VAT)

    Time frame · Baseline, Week 72

    Registry description

    Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  14. Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)

    Time frame · Baseline, Week 72

    Registry description

    Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  15. Change From Baseline in VAT/SAT Ratio

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  16. Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline

    Time frame · Week 72

    Registry description

    Percentage of Participants Who Achieve VAT \<100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.

  17. Change From Baseline in Waist Circumference

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  18. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  19. Change From Baseline in Fasting Insulin for Participants With IGT at Baseline

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

  20. Change From Baseline in Systolic Blood Pressure

    Time frame · Baseline, Week 72

    Registry description

    Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 72 Weeks

Mean Percent Change in Body Weight

GroupValue (Percent change)Spread
10 mg Tirzepatide-17.80.94
15 mg Tirzepatide-22.70.90
Placebo-1.70.90
Primary outcomeNumber· Week 72

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

GroupValue (Percentage of participants)
10 mg Tirzepatide94.37
15 mg Tirzepatide96.05
Placebo20
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 72

Percentage of Participants Who Had Improvement in Obesity-related Health Problems

GroupValue (Percentage of participants)
10 mg Tirzepatide70.0
15 mg Tirzepatide79.69
Placebo11.11
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

GroupValue (milligrams per deciliter (mg/dL))Spread
10 mg Tirzepatide-12.811.490
15 mg Tirzepatide-10.611.391
Placebo2.191.291
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

GroupValue (milligrams per deciliter (mg/dL))Spread
10 mg Tirzepatide-61.505.330
15 mg Tirzepatide-70.564.951
Placebo-5.744.612
Secondary outcomeLeast squares mean· Baseline, Week 72

Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

GroupValue (Percent change)Spread
10 mg Tirzepatide-47.33.34
15 mg Tirzepatide-50.62.77
Placebo-11.05.14
Secondary outcomeLeast squares mean· Baseline, Week 72

Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

GroupValue (Percent change)Spread
10 mg Tirzepatide-63.93.09
15 mg Tirzepatide-69.92.99
Placebo-19.63.05
Secondary outcomeNumber· Week 72

Percentage of Participants Who Achieved Improvements of IGT

GroupValue (Percentage of participants)
10 mg Tirzepatide92.50
15 mg Tirzepatide97.83
Placebo28.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
10 mg TirzepatideParticipants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide SC QW .0 / 738 / 7359 / 73
15 mg TirzepatideParticipants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.0 / 775 / 7765 / 77
PlaceboParticipants received matching placebo administered SC QW.0 / 755 / 7551 / 75

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2026

12 results

Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial.

Yokote et al. 2026Diabetes, obesity & metabolismcited by 5

PMID 41290555PMC12803658DOI 10.1111/dom.70315PUB-41290555

Free to read · publisher termsCC BY-NC12 results
Read at sourceSee results (12)

Indexing hint: Randomized controlled trial · 2026

7 results

Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study.

Masuzaki et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42108080PMC13341361DOI 10.1111/dom.70850PUB-42108080

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Indexing hint: Randomized controlled trial · 2026

4 results

Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease.

Node et al. 2026Current medical research and opinion

PMID 42287159DOI 10.1080/03007995.2026.2686052PUB-42287159

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 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 et al. 2025The lancet. Diabetes & endocrinologycited by 27

PMID 40031941DOI 10.1016/s2213-8587(24)00377-2PUB-40031941

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have a BMI of greater than or equal to ≥27 kg/m² and \<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD. * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: * Have diabetes. * Acute or chronic liver disease other than NAFLD. * Have a self-reported change in body weight \>5 kg within 3 months prior to screening. * Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening. * Have a known clinically significant gastric emptying abnormality. * Have had a history of chronic or acute pancreatitis. * Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening. * Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. * Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years. * Have a cardiovascular condition within 3 months prior to randomization * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.

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