ObesityPhase 3SURMOUNT-JNCT04844918
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
A Phase 3 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 18 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 18 sitesJapan
- Study dates
- 10 May 2021to 24 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
The Institute for Adult Disease, Asahi Life Foundation
Chuo-ku, Tokyo, 103-0002
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Medical Corporation Chiseikai Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Kohnodai Hospital, National Center for Global Health and Medicine
Ichikawa, Chiba, 272-8516
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026
Saiseikai Central Hospital
Minato-Ku, Tokyo, 108-0073
AMC Nishiumeda Clinic
Osaka, 530-0001
Shimokitazawa Tomo Clinic
Setagaya-ku, Tokyo, 155-0031
Miho Clinic
Shinagawa-ku, Tokyo, 141 0032
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160 0008
Osaka Saiseikai Suita hospital
Suita, Osaka, 564-0013
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1045
Yamagata Tokushukai Hospital
Yamagata, Yamagata, 990-0834
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 2308765
Motomachi Takatsuka Naika Clinic
Yokohama, Kanagawa, 231-0023
About this study
Official title: Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
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.
- Conditions
- Obesity
- Being tested
- Tirzepatide, Placebo
- Keywords
- Metabolism and Nutrition Disorder, Obesity Related Health Problems, Obesity Disease
- Medical subject headings
- Obesity, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboOther
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 10 Milligrams (mg) Tirzepatide | Experimental | 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). Receives: Drug: Tirzepatide |
| 15 mg Tirzepatide | Experimental | 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. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants received matching placebo administered SC QW. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Body Weight
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.
Measured: Baseline, 72 Weeks
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Measured: Week 72
Secondary outcomes (24)
Percentage of Participants Who Had Improvement in Obesity-related Health Problems
Percentage of participants who had improvement in obesity-related health problems
Measured: Week 72
Change From Baseline in Fasting Glucose for Participants With IGT at Baseline
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.
Measured: Baseline, Week 72
Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline
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.
Measured: Baseline, Week 72
Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline
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.
Measured: Baseline, Week 72
Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]
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.
Measured: Baseline, Week 72
Percentage of Participants Who Achieved Improvements of IGT
Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.
Measured: Week 72
Percentage of Participants Who Achieved Improvements of Hyperlipidemia
Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.
Measured: Week 72
Percentage of Participants Who Achieved Improvements of NAFLD
Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.
Measured: Week 72
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥10% body weight reduction.
Measured: Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% body weight reduction.
Measured: Week 72
Change From Baseline in Absolute Body Weight
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.
Measured: Baseline, Week 72
Change From Baseline in Body Mass Index (BMI)
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.
Measured: Baseline, Week 72
Percent Change From Baseline in Visceral Adipose Tissue (VAT)
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.
Measured: Baseline, Week 72
Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)
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.
Measured: Baseline, Week 72
Change From Baseline in VAT/SAT Ratio
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.
Measured: Baseline, Week 72
Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline
Percentage of Participants Who Achieve VAT <100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.
Measured: Week 72
Change From Baseline in Waist Circumference
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.
Measured: Baseline, Week 72
Change From Baseline in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline, Week 72
Change From Baseline in Fasting Insulin for Participants With IGT at Baseline
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.
Measured: Baseline, Week 72
Change From Baseline in Systolic Blood Pressure
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.
Measured: Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure
Change from Baseline in Diastolic 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.
Measured: Baseline, Week 72
Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.
Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Measured: Baseline, Week 72
Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Measured: Baseline, Week 72
Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between
˂0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Measured: Baseline, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start10 May 2021
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844918
- Sponsor's protocol ID
- 17506
- Other IDs
- I8F-JE-GPHZ
- Acronym
- SURMOUNT-J
- Status last verified
- Jun 2024
- First submitted
- 1 Apr 2021
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Node K, Batterham RL, Liu-Seifert H, Li R, Yoshino M, Oura T, Tanizawa Y, Komuro I. Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease. Curr Med Res Opin. 2026 Apr;42(4):751-763. doi: 10.1080/03007995.2026.2686052. Epub 2026 Jun 13.
PubMed 42287159Masuzaki H, Nagashima H, Shingaki T, Oura T, Tatsuno I. Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study. Diabetes Obes Metab. 2026 Aug;28(8):6639-6648. doi: 10.1111/dom.70850. Epub 2026 May 10.
PubMed 42108080Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2026 Feb;28(2):1278-1287. doi: 10.1111/dom.70315. Epub 2025 Nov 25.
PubMed 41290555Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. 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. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28.
PubMed 40031941
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
- ClinicalTrials.gov ID
- NCT04844918
- Acronym / sponsor ID
- SURMOUNT-J / 17506
- Conditions
- Obesity
- Keywords
- Metabolism and Nutrition Disorder, Obesity Related Health Problems, Obesity Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 Milligrams (mg) Tirzepatide | Experimental | Drug: TirzepatideParticipants 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). |
| 15 mg Tirzepatide | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received matching placebo administered SC QW. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | 10 Milligrams (mg) Tirzepatide, 15 mg Tirzepatide |
| PlaceboAdministered SC | Other | Placebo |
Primary outcome
Mean Percent Change in Body Weight
Time frame: Baseline, 72 Weeks
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.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: Week 72
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
24 secondary outcomes
Percentage of Participants Who Had Improvement in Obesity-related Health Problems
Time frame: Week 72
Change From Baseline in Fasting Glucose for Participants With IGT at Baseline
Time frame: Baseline, Week 72
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
Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline
Time frame: Baseline, Week 72
Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]
Time frame: Baseline, Week 72
Percentage of Participants Who Achieved Improvements of IGT
Time frame: Week 72
Percentage of Participants Who Achieved Improvements of Hyperlipidemia
Time frame: Week 72
Percentage of Participants Who Achieved Improvements of NAFLD
Time frame: Week 72
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame: Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: Week 72
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 72
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
Percent Change From Baseline in Visceral Adipose Tissue (VAT)
Time frame: Baseline, Week 72
Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)
Time frame: Baseline, Week 72
Change From Baseline in VAT/SAT Ratio
Time frame: Baseline, Week 72
Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline
Time frame: Week 72
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 72
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 72
Change From Baseline in Fasting Insulin for Participants With IGT at Baseline
Time frame: Baseline, Week 72
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, Week 72
Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame: Baseline, Week 72
Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame: Baseline, Week 72
Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)
Time frame: Baseline, Week 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42287159Node K, Batterham RL, Liu-Seifert H, Li R, Yoshino M, Oura T, Tanizawa Y, Komuro I. Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease. Curr Med Res Opin. 2026 Apr;42(4):751-763. doi: 10.1080/03007995.2026.2686052. Epub 2026 Jun 13.
- Derived from this study: PubMed 42108080Masuzaki H, Nagashima H, Shingaki T, Oura T, Tatsuno I. Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study. Diabetes Obes Metab. 2026 Aug;28(8):6639-6648. doi: 10.1111/dom.70850. Epub 2026 May 10.
- Derived from this study: PubMed 41290555Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2026 Feb;28(2):1278-1287. doi: 10.1111/dom.70315. Epub 2025 Nov 25.
- Derived from this study: PubMed 40031941Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. 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. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLilly (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT -5 hours, EST) study director
Eli Lilly and Company
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Obesity, run by Eli Lilly and Company at 18 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in Body Weight (time frame: Baseline, 72 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.