Phase 3 · Tirzepatide

SURMOUNT-CN trial results

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

Mean Percent Change From Baseline in Body Weight (Percent change), Baseline, Week 52. 10 mg Tirzepatide: -14.4; 15 mg Tirzepatide: -19.9; Placebo: -2.4.

Participants
210
Status
completed
Completed
2022-12-27
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05024032), updated at source Jan 19, 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-CN measured first

Mean Percent Change From Baseline in Body WeightPercent change · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
-14.4(0.98)-19.9(1.01)-2.4(1.00)
Percentage of Participants Who Achieve ≥5% Body Weight ReductionPercentage of participants · Week 52 · number
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
91.4392.6529.41
Side effects by arm

Side effects in SURMOUNT-CN

Percent of participants affected, Baseline Through Safety Follow-Up (Up To Week 56). The most common events the registry lists.

Event10 mg Tirzepatide15 mg TirzepatidePlacebo
Any serious event4.3%11.3%8.7%
Diarrhoea40%40.8%8.7%
Nausea30%32.4%5.8%
Decreased appetite27.1%28.2%11.6%
Upper respiratory tract infection22.9%23.9%17.4%
Vomiting11.4%19.7%4.3%
Abdominal distension18.6%12.7%1.4%
Hyperuricaemia4.3%7%11.6%
Gastroenteritis11.4%2.8%0%
Vaginal infection2.9%5.7%9.1%
Hepatic function abnormal4.3%1.4%8.7%
Flatulence8.6%8.5%0%
Abortion induced8.6%2.9%3%
Abdominal pain upper7.1%2.8%0%
Gingivitis7.1%1.4%0%
Amylase increased7.1%1.4%0%
Lipase increased7.1%7%0%
Abdominal pain5.7%7%2.9%
Injection site reaction5.7%2.8%0%
Menstruation irregular5.7%0%3%
Dizziness2.9%5.6%4.3%
Hiccups1.4%5.6%0%
Secondary outcomes

What else it measured

Mean Change From Baseline in Body Weightkilograms (kg) · Baseline, Week 20 · least squares mean
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
-9.0(0.59)-11.1(0.61)-1.8(0.60)
Percentage of Participants Who Achieve ≥10% Body Weight ReductionPercentage of participants · Week 52 · number
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
70.083.8214.71
Percentage of Participants Who Achieve ≥15% Body Weight ReductionPercentage of participants · Week 52 · number
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
48.5772.062.94
Mean Change From Baseline in Waist Circumferencecentimeters (cm) · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
-11.9(0.83)-16.4(0.85)-2.7(0.84)
Mean Change From Baseline in Absolute Body Weightkilograms (kg) · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
-13.1(0.93)-18.1(0.95)-2.1(0.94)
Mean Change From Baseline in Body Mass Index (BMI)kilograms per metres squared (kg/m^2) · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=7015 mg Tirzepatiden=68Placebon=68
-4.7(0.29)-6.4(0.30)-0.8(0.30)
Mean Change From Baseline in Hemoglobin A1c (HbA1c)Percentage of HbA1c · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=6915 mg Tirzepatiden=66Placebon=67
-0.34(0.032)-0.35(0.033)0.03(0.033)
Mean Change From Baseline in Fasting Glucose (FSG)millimoles per liter (mmol/L) · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=6915 mg Tirzepatiden=66Placebon=67
-0.25(0.050)-0.33(0.052)0.22(0.051)
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain ScoreScore on a scale · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=6215 mg Tirzepatiden=58Placebon=58
2.0(0.40)1.9(0.42)0.8(0.41)
Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite ScoreScore on a scale · Baseline, Week 52 · least squares mean
10 mg Tirzepatiden=6215 mg Tirzepatiden=58Placebon=58
11.2(1.44)12.0(1.48)3.5(1.48)
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)millimeters of Mercury (mmHg) · Baseline, Week 52 · least squares mean
Tirzepatide Pooled Analysisn=119Placebon=58
-6.1(0.62)-1.3(0.88)
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)millimeters of Mercury (mmHg) · Baseline, Week 52 · least squares mean
Tirzepatide Pooled Analysisn=119Placebon=58
-9.6(0.87)-3.5(1.24)
The trial

How SURMOUNT-CN was run

This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.

  • 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 SC QW.
Who could join the trial

Inclusion Criteria: * Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * Have a history of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * Have Diabetes Mellitus * Have a self-reported change in body weight \>5 kg within 3 months prior to screening * Have obesity induced by other endocrinological disorders * Have had a history of chronic or acute pancreatitis * Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years * Have any lifetime history of a suicide attempt * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Published papers

Papers from SURMOUNT-CN

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.