Phase 3 · Tirzepatide

SURMOUNT-3 trial results

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)

Percent Change From Baseline in Body Weight (Percent change), Baseline, 72 Weeks. Placebo: 3.3; Tirzepatide: -21.1.

Participants
579
Status
completed
Completed
2023-05-12
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT04657016), updated at source May 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-3 measured first

Percent Change From Baseline in Body WeightPercent change · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
3.3(0.60)-21.1(0.59)
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reductionpercentage of participants · Week 72 · number
Placebon=291Tirzepatiden=284
10.6594.37
Side effects by arm

Side effects in SURMOUNT-3

Percent of participants affected, Baseline up to week 76. The most common events the registry lists.

EventPlaceboTirzepatide
Any serious event4.8%5.9%
Nausea14%39.7%
Diarrhoea9.2%31%
Covid-1925.3%23%
Constipation6.8%23%
Vomiting1.4%18.1%
Injection site reaction1%11.1%
Abdominal pain2.4%10.5%
Dyspepsia3.1%9.4%
Decreased appetite4.1%9.4%
Headache7.5%9.4%
Upper respiratory tract infection7.2%8.7%
Influenza8.6%4.2%
Fatigue3.1%7%
Dizziness2.1%7%
Alopecia1.4%7%
Flatulence2.7%6.6%
Gastrooesophageal reflux disease2.4%6.6%
Anxiety6.5%3.1%
Back pain5.1%5.9%
Eructation1%5.6%
Sinusitis5.5%2.1%
Arthralgia5.1%2.4%
Secondary outcomes

What else it measured

Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Programpercentage of participants · 72 Weeks · number
Placebon=291Tirzepatiden=284
37.8098.59
Percentage of Participants Who Achieve ≥10%Body Weight Reductionpercentage of participants · 72 Weeks · number
Placebon=291Tirzepatiden=284
4.8188.03
Percentage of Participants Who Achieve ≥15% Body Weight ReductionPercentage of participants · 72 Weeks · number
Placebon=291Tirzepatiden=284
2.0673.94
Percentage of Participants Who Achieve ≥20% Body Weight ReductionPercentage of participants · 72 Weeks · number
Placebon=291Tirzepatiden=284
1.0354.93
Change From Baseline in Waist CircumferenceCentimeters (Cms) · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
1.1(0.58)-16.8(0.56)
Change From Baseline in Body Weightkg · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
3.5(0.67)-21.5(0.65)
Change From Baseline in Body Mass Index (BMI)kilogram per meter square (kg/m^2) · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
1.2(0.23)-7.7(0.23)
Change From Baseline in Systolic Blood Pressure (SBP)millimeters of mercury (mmHg) · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
4.4(0.76)-5.8(0.73)
Change From Baseline in Diastolic Blood Pressure (DBP)mmHg · Baseline, 72 Weeks · least squares mean
Placebon=291Tirzepatiden=284
2.3(0.53)-3.4(0.51)
Percent Change From Baseline in Total CholesterolPercent change · Baseline, 72 Weeks · least squares mean
Placebon=252Tirzepatiden=263
5.19(1.11)-3.00(0.97)
Percent Change From Baseline in High Density Lipoprotein (HDL) CholesterolPercent change · Baseline, 72 Weeks · least squares mean
Placebon=252Tirzepatiden=263
3.6(1.12)15.4(1.19)
Percent Change From Baseline in Low Density Lipoprotein (LDL) CholesterolPercent change · Baseline, 72 Weeks · least squares mean
Placebon=252Tirzepatiden=263
6.14(1.71)-6.07(1.44)
The trial

How SURMOUNT-3 was run

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

  • Tirzepatide: Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
  • Placebo: Participants received matching placebo SC once weekly (QW).
Who could join the trial

Inclusion Criteria: * Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease * History of at least one unsuccessful dietary effort to lose body weight Exclusion Criteria: * Diabetes mellitus * Change in body weight greater than 5 kg within 3 months prior to starting study * Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * History of pancreatitis * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years * Any lifetime history of a suicide attempt

Published papers

Papers from SURMOUNT-3

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.