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Completed

NCT Number: NCT05024032

A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

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.

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Key information

Conditions

Obesity Body Weight Metabolism and Nutrition Disorder Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. Mean Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 52

    Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Time frame: Week 52

    Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.

Secondary outcomes

  1. Mean Change From Baseline in Body Weight

    Time frame: Baseline, Week 20

    Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  2. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Time frame: Week 52

    Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.

  3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame: Week 52

    Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.

  4. Mean Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 52

    Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  5. Mean Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 52

    Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  6. Mean Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 52

    Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  7. Mean Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 52

    Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  8. Mean Change From Baseline in Fasting Glucose (FSG)

    Time frame: Baseline, Week 52

    Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  9. Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Time frame: Baseline, Week 52

    The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary.

    Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

    LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.

  10. Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Time frame: Baseline, Week 52

    The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.

  11. Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  12. Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  13. Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  14. Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  15. Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  16. Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  17. Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  18. Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

  19. Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 52

    LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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)

Acronym: SURMOUNT-CN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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