Phase 3
Completed N=267
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Source: ClinicalTrials.gov NCT04844918 ↗Enrolled (actual)
267
Serious AEs
8.0%
Results posted
Jul 2024
Primary outcomePrimary: Mean Percent Change in Body Weight — -17.8; -22.7; -1.7 Percent change — p=<0.001
◆ Published Evidence
Established
34citations · ~34 / year
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.
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.
Linked Publications (3)
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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.
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Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial.
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Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Body Weight |
-17.8; -22.7; -1.7 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieve ≥5% Body Weight Reduction |
94.37; 96.05; 20 | <0.001 sig |
| SECONDARY Percentage of Participants Who Had Improvement in Obesity-related Health Problems |
70.0; 79.69; 11.11 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Glucose for Participants With IGT at Baseline |
-12.81; -10.61; 2.19 | <0.001 sig |
| SECONDARY Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline |
-61.50; -70.56; -5.74 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline |
-47.3; -50.6; -11.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD] |
-63.9; -69.9; -19.6 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Improvements of IGT |
92.50; 97.83; 28.0 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Improvements of Hyperlipidemia |
72.41; 81.08; 25 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Improvements of NAFLD |
69.49; 77.42; 9.84 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥10% Body Weight Reduction |
85.92; 92.11; 4 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction |
63.38; 82.89; 1.33 | <0.001 sig |
| SECONDARY Change From Baseline in Absolute Body Weight |
-16.0; -20.8; -1.5 | <0.001 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
-5.8; -7.7; -0.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Visceral Adipose Tissue (VAT) |
-39.4; -44.5; -3.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT) |
-32.2; -36.5; -5.0 | <0.001 sig |
| SECONDARY Change From Baseline in VAT/SAT Ratio |
-0.09; -0.08; 0.01 | 0.004 sig |
| SECONDARY Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline |
26.32; 37.10; 1.64 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference |
-12.7; -16.6; -1.3 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.67; -0.68; -0.02 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Insulin for Participants With IGT at Baseline |
-6.04; -6.69; -2.13 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
-11.2; -12.0; 1.9 | <0.001 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
-5.9; -6.3; 0.5 | <0.001 sig |
| SECONDARY Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score |
1.1; 2.0; -0.1 | 0.022 sig |
| SECONDARY Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score |
15.2; 13.0; 2.2 | <0.001 sig |
| SECONDARY Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L) |
0.01; 0.01; -0.01 | 0.099 |
Eligibility Criteria
Inclusion Criteria
- Have a BMI of greater than or equal to ≥27 kg/m² and 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.
Data sourced from ClinicalTrials.gov (NCT04844918) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.