Phase 3 · Tirzepatide

SURMOUNT-2 trial results

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

Percent Change From Baseline in Body Weight (percent change), Baseline, Week 72. Placebo: -3.3; 10 mg Tirzepatide: -13.4; 15 mg Tirzepatide: -15.7.

Participants
938
Status
completed
Completed
2023-04-10
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT04657003), updated at source Apr 8, 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-2 measured first

Percent Change From Baseline in Body Weightpercent change · Baseline, Week 72 · least squares mean
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
-3.3(0.49)-13.4(0.48)-15.7(0.49)
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baselinepercentage of participants · Week 72 · number
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
30.5581.5586.41
Side effects by arm

Side effects in SURMOUNT-2

Percent of participants affected, Baseline through Week 76. The most common events the registry lists.

EventPlacebo10 mg Tirzepatide15 mg Tirzepatide
Any serious event7.3%5.8%8.7%
Nausea6.3%20.2%21.9%
Diarrhoea8.9%19.9%21.2%
Covid-1916.8%16.7%10.6%
Hyperglycaemia14.3%1.9%1.3%
Vomiting3.2%10.9%12.9%
Decreased appetite2.2%9.6%10%
Constipation4.1%8%9%
Abdominal pain2.2%3.8%7.4%
Dyspepsia3.2%7.4%7.1%
Upper respiratory tract infection6.7%3.2%3.9%
Eructation0.6%6.1%4.2%
Nasopharyngitis5.4%2.9%3.2%
Dizziness1.6%5.4%2.6%
Headache2.9%5.1%4.8%
Secondary outcomes

What else it measured

Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baselinepercentage of participants · Week 72 · number
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
8.6863.4369.58
Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baselinepercentage of participants · Week 72 · number
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
2.5741.4251.78
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baselinepercentage of participants · Week 72 · number
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
0.9622.9833.98
Change From Baseline in Absolute Body Weightkilograms (kg) · Baseline, Week 72 · least squares mean
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
-3.2(0.51)-13.5(0.51)-15.6(0.51)
Change From Baseline in Body Mass Index (BMI)kilograms per meter squared (kg/m^2) · Baseline, Week 72 · least squares mean
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
-1.2(0.19)-4.9(0.18)-5.7(0.19)
Change From Baseline in Hemoglobin A1c (HbA1c)percentage of HbA1c · Baseline, Week 72 · least squares mean
Placebon=29010 mg Tirzepatiden=30115 mg Tirzepatiden=300
-0.16(0.067)-2.14(0.060)-2.22(0.060)
Percentage of Participants Who Achieve HbA1c <7%percentage of participants · Week 72 · number
Placebon=29010 mg Tirzepatiden=30115 mg Tirzepatiden=300
29.3190.0390.67
Percentage of Participants Who Achieve HbA1c ≤6.5%percentage of participants · Week 72 · number
Placebon=29010 mg Tirzepatiden=30115 mg Tirzepatiden=300
15.5284.0586.67
Percentage of Participants Who Achieve HbA1c <5.7%percentage of participants · Week 72 · number
Placebon=29010 mg Tirzepatiden=30115 mg Tirzepatiden=300
2.7650.1755.33
Change From Baseline in Fasting Glucosemilligrams per deciliter (mg/dL) · Baseline, Week 72 · least squares mean
Placebon=29010 mg Tirzepatiden=30015 mg Tirzepatiden=300
-2.42(2.281)-49.20(1.940)-51.67(1.970)
Change From Baseline in Waist Circumferencecentimeters (cm) · Baseline, Week 72 · least squares mean
Placebon=31110 mg Tirzepatiden=30915 mg Tirzepatiden=309
-3.4(0.51)-11.2(0.50)-13.8(0.51)
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)percent change · Baseline, Week 72 · mean
Placebon=292Pooled 10 mg and 15 mg Tirzepatiden=587
2.13(1.135)-2.58(0.755)
The trial

How SURMOUNT-2 was run

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

  • 10 milligrams (mg) Tirzepatide: 10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)
  • 15 mg Tirzepatide: 15 mg Tirzepatide administered SC QW
  • Placebo: Placebo administered SC QW
Who could join the trial

Inclusion Criteria: * Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs) * Have a BMI of ≥27 kg/m² * Are overweight or have obesity * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight * Are at least 18 years of age and age of majority per local laws and regulations Exclusion Criteria: * Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM * Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3 * Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment * Have self-reported change in body weight \>5kg within 3 months prior to screening * Have had a history of chronic or acute pancreatitis * 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 * 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-2

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.