What SURMOUNT-2 measured first
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| -3.3(0.49) | -13.4(0.48) | -15.7(0.49) |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| 30.55 | 81.55 | 86.41 |
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.
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.
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| -3.3(0.49) | -13.4(0.48) | -15.7(0.49) |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| 30.55 | 81.55 | 86.41 |
Percent of participants affected, Baseline through Week 76. The most common events the registry lists.
| Event | Placebo | 10 mg Tirzepatide | 15 mg Tirzepatide |
|---|---|---|---|
| Any serious event | 7.3% | 5.8% | 8.7% |
| Nausea | 6.3% | 20.2% | 21.9% |
| Diarrhoea | 8.9% | 19.9% | 21.2% |
| Covid-19 | 16.8% | 16.7% | 10.6% |
| Hyperglycaemia | 14.3% | 1.9% | 1.3% |
| Vomiting | 3.2% | 10.9% | 12.9% |
| Decreased appetite | 2.2% | 9.6% | 10% |
| Constipation | 4.1% | 8% | 9% |
| Abdominal pain | 2.2% | 3.8% | 7.4% |
| Dyspepsia | 3.2% | 7.4% | 7.1% |
| Upper respiratory tract infection | 6.7% | 3.2% | 3.9% |
| Eructation | 0.6% | 6.1% | 4.2% |
| Nasopharyngitis | 5.4% | 2.9% | 3.2% |
| Dizziness | 1.6% | 5.4% | 2.6% |
| Headache | 2.9% | 5.1% | 4.8% |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| 8.68 | 63.43 | 69.58 |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| 2.57 | 41.42 | 51.78 |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| 0.96 | 22.98 | 33.98 |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| -3.2(0.51) | -13.5(0.51) | -15.6(0.51) |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| -1.2(0.19) | -4.9(0.18) | -5.7(0.19) |
| Placebon=290 | 10 mg Tirzepatiden=301 | 15 mg Tirzepatiden=300 |
|---|---|---|
| -0.16(0.067) | -2.14(0.060) | -2.22(0.060) |
| Placebon=290 | 10 mg Tirzepatiden=301 | 15 mg Tirzepatiden=300 |
|---|---|---|
| 29.31 | 90.03 | 90.67 |
| Placebon=290 | 10 mg Tirzepatiden=301 | 15 mg Tirzepatiden=300 |
|---|---|---|
| 15.52 | 84.05 | 86.67 |
| Placebon=290 | 10 mg Tirzepatiden=301 | 15 mg Tirzepatiden=300 |
|---|---|---|
| 2.76 | 50.17 | 55.33 |
| Placebon=290 | 10 mg Tirzepatiden=300 | 15 mg Tirzepatiden=300 |
|---|---|---|
| -2.42(2.281) | -49.20(1.940) | -51.67(1.970) |
| Placebon=311 | 10 mg Tirzepatiden=309 | 15 mg Tirzepatiden=309 |
|---|---|---|
| -3.4(0.51) | -11.2(0.50) | -13.8(0.51) |
| Placebon=292 | Pooled 10 mg and 15 mg Tirzepatiden=587 |
|---|---|
| 2.13(1.135) | -2.58(0.755) |
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).
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.