Phase 3 · Tirzepatide

SURMOUNT-J trial results

Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)

Mean Percent Change in Body Weight (Percent change), Baseline, 72 Weeks. 10 mg Tirzepatide: -17.8; 15 mg Tirzepatide: -22.7; Placebo: -1.7.

Participants
267
Status
completed
Completed
2023-06-24
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT04844918), updated at source Jul 16, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SURMOUNT-J measured first

Mean Percent Change in Body WeightPercent change · Baseline, 72 Weeks · least squares mean
10 mg Tirzepatiden=5915 mg Tirzepatiden=65Placebon=66
-17.8(0.94)-22.7(0.90)-1.7(0.90)
Percentage of Participants Who Achieve ≥5% Body Weight ReductionPercentage of participants · Week 72 · number
10 mg Tirzepatiden=7115 mg Tirzepatiden=76Placebon=75
94.3796.0520
Side effects by arm

Side effects in SURMOUNT-J

Percent of participants affected, Baseline Through Safety Follow-Up (Up To 76 Weeks). The most common events the registry lists.

Event10 mg Tirzepatide15 mg TirzepatidePlacebo
Any serious event11%6.5%6.7%
Constipation16.4%27.3%6.7%
Nausea13.7%23.4%4%
Covid-1920.5%19.5%17.3%
Pyrexia13.7%14.3%14.7%
Diarrhoea12.3%9.1%4%
Decreased appetite12.3%7.8%1.3%
Vomiting6.8%11.7%4%
Nasopharyngitis9.6%1.3%10.7%
Abdominal discomfort6.8%5.2%0%
Headache2.7%2.6%6.7%
Injection site reaction5.5%5.2%0%
Back pain5.5%3.9%5.3%
Immunisation reaction1.4%5.2%5.3%
Arthralgia1.4%5.2%1.3%
Abdominal pain upper4.1%3.9%2.7%
Herpes zoster4.1%0%1.3%
Amylase increased4.1%2.6%0%
Dental caries1.4%1.3%4%
Contusion0%1.3%4%
Albumin urine present0%0%4%
Type 2 diabetes mellitus0%0%4%
Dyspepsia2.7%3.9%1.3%
Malaise2.7%3.9%0%
Cystitis0%3.9%1.3%
Dizziness1.4%3.9%1.3%
Secondary outcomes

What else it measured

Percentage of Participants Who Had Improvement in Obesity-related Health ProblemsPercentage of participants · Week 72 · number
10 mg Tirzepatiden=6015 mg Tirzepatiden=64Placebon=63
70.079.6911.11
Change From Baseline in Fasting Glucose for Participants With IGT at Baselinemilligrams per deciliter (mg/dL) · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=3515 mg Tirzepatiden=40Placebon=47
-12.81(1.490)-10.61(1.391)2.19(1.291)
Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baselinemilligrams per deciliter (mg/dL) · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=3515 mg Tirzepatiden=40Placebon=47
-61.50(5.330)-70.56(4.951)-5.74(4.612)
Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at BaselinePercent change · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=2915 mg Tirzepatiden=37Placebon=36
-47.3(3.34)-50.6(2.77)-11.0(5.14)
Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]Percent change · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=5915 mg Tirzepatiden=62Placebon=61
-63.9(3.09)-69.9(2.99)-19.6(3.05)
Percentage of Participants Who Achieved Improvements of IGTPercentage of participants · Week 72 · number
10 mg Tirzepatiden=4015 mg Tirzepatiden=46Placebon=50
92.5097.8328.0
Percentage of Participants Who Achieved Improvements of HyperlipidemiaPercentage of participants · Week 72 · number
10 mg Tirzepatiden=2915 mg Tirzepatiden=37Placebon=36
72.4181.0825
Percentage of Participants Who Achieved Improvements of NAFLDPercentage of participants · Week 72 · number
10 mg Tirzepatiden=5915 mg Tirzepatiden=62Placebon=61
69.4977.429.84
Percentage of Participants Who Achieve ≥10% Body Weight ReductionPercentage of participants · Week 72 · number
10 mg Tirzepatiden=7115 mg Tirzepatiden=76Placebon=75
85.9292.114
Percentage of Participants Who Achieve ≥15% Body Weight ReductionPercentage of participants · Week 72 · number
10 mg Tirzepatiden=7115 mg Tirzepatiden=76Placebon=75
63.3882.891.33
Change From Baseline in Absolute Body Weightkilograms (kg) · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=5915 mg Tirzepatiden=65Placebon=66
-16.0(0.86)-20.8(0.82)-1.5(0.82)
Change From Baseline in Body Mass Index (BMI)kilograms per metres squared (kg/m^2) · Baseline, Week 72 · least squares mean
10 mg Tirzepatiden=5915 mg Tirzepatiden=65Placebon=66
-5.8(0.32)-7.7(0.30)-0.6(0.30)
The trial

How SURMOUNT-J was run

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.

  • 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).
  • 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: Participants received matching placebo administered SC QW.
Who could join the trial

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.

Published papers

Papers from SURMOUNT-J

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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