Phase 3
N=210
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Obesity · Overweight · Metabolism and Nutrition Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05024032 ↗Enrolled (actual)
210
Serious AEs
8.1%
Results posted
Jan 2024
Primary outcome: Primary: Mean Percent Change From Baseline in Body Weight — -14.4; -19.9; -2.4 Percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tirzepatide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in Body Weight |
-14.4; -19.9; -2.4 | <0.001 sig |
| PRIMARY Percentage of Participants Who Achieve ≥5% Body Weight Reduction |
91.43; 92.65; 29.41 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Body Weight |
-9.0; -11.1; -1.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥10% Body Weight Reduction |
70.0; 83.82; 14.71 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction |
48.57; 72.06; 2.94 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Waist Circumference |
-11.9; -16.4; -2.7 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Absolute Body Weight |
-13.1; -18.1; -2.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Body Mass Index (BMI) |
-4.7; -6.4; -0.8 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.34; -0.35; 0.03 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Fasting Glucose (FSG) |
-0.25; -0.33; 0.22 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score |
2.0; 1.9; 0.8 | 0.044 sig |
| SECONDARY Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score |
11.2; 12.0; 3.5 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-6.1; -1.3 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-9.6; -3.5 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-0.37; -0.06 | — |
| SECONDARY Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
0.12; 0.03 | — |
| SECONDARY Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-0.17; -0.11 | — |
| SECONDARY Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-0.28; -0.03 | — |
| SECONDARY Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-0.63; -0.05 | — |
| SECONDARY Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-0.16; -0.10 | — |
| SECONDARY Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) |
-6.5; -0.2 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05024032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.