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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURMOUNT-CN

NCTNCT05024032 (opens ClinicalTrials.gov in a new tab)Other id17507Other idI8F-MC-GPIA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
210 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
1 Sept 2021
Primary completion
27 Dec 2022
Completion
27 Dec 2022
First posted
27 Aug 2021
Last update posted
19 Jan 2024
Conditions
Obesity · Overweight · Metabolism and Nutrition Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 3

    SURMOUNT-CN

    NCT05024032

    1 Sept 2021 to 27 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • PlaceboDrug

Arms3

  • Experimental

    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).

  • Experimental

    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 comparator

    Placebo

    Participants received matching placebo SC QW.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Mean Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 52

    Registry description

    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

    Registry description

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

Secondary outcomes(19)

  1. Mean Change From Baseline in Body Weight

    Time frame · Baseline, Week 20

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 52

Mean Percent Change From Baseline in Body Weight

GroupValue (Percent change)Spread
10 mg Tirzepatide-14.40.98
15 mg Tirzepatide-19.91.01
Placebo-2.41.00
Primary outcomeNumber· Week 52

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

GroupValue (Percentage of participants)
10 mg Tirzepatide91.43
15 mg Tirzepatide92.65
Placebo29.41
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Baseline, Week 20

Mean Change From Baseline in Body Weight

GroupValue (kilograms (kg))Spread
10 mg Tirzepatide-9.00.59
15 mg Tirzepatide-11.10.61
Placebo-1.80.60
Secondary outcomeNumber· Week 52

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

GroupValue (Percentage of participants)
10 mg Tirzepatide70.0
15 mg Tirzepatide83.82
Placebo14.71
Secondary outcomeNumber· Week 52

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

GroupValue (Percentage of participants)
10 mg Tirzepatide48.57
15 mg Tirzepatide72.06
Placebo2.94
Secondary outcomeLeast squares mean· Baseline, Week 52

Mean Change From Baseline in Waist Circumference

GroupValue (centimeters (cm))Spread
10 mg Tirzepatide-11.90.83
15 mg Tirzepatide-16.40.85
Placebo-2.70.84
Secondary outcomeLeast squares mean· Baseline, Week 52

Mean Change From Baseline in Absolute Body Weight

GroupValue (kilograms (kg))Spread
10 mg Tirzepatide-13.10.93
15 mg Tirzepatide-18.10.95
Placebo-2.10.94
Secondary outcomeLeast squares mean· Baseline, Week 52

Mean Change From Baseline in Body Mass Index (BMI)

GroupValue (kilograms per metres squared (kg/m^2))Spread
10 mg Tirzepatide-4.70.29
15 mg Tirzepatide-6.40.30
Placebo-0.80.30

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
10 mg TirzepatideParticipants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW.0 / 703 / 7061 / 70
15 mg TirzepatideParticipants 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.0 / 718 / 7156 / 71
PlaceboParticipants received matching placebo SC QW.0 / 696 / 6939 / 69

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2024

Corrected

Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial.

Zhao et al. 2024JAMAcited by 108

PMID 38819983PMC11337071DOI 10.1001/jama.2024.9217PUB-38819983

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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