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A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Phase 3 trial testing Tirzepatide in Obesity in 210 participants. Completed in 27 December 2022.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 1 September 2021 |
| Primary completion | 27 December 2022 |
| Estimated completion | 27 December 2022 |
| Sites | 29 locations across China |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -14.4 | ± 0.98 |
| 15 mg Tirzepatide | -19.9 | ± 1.01 |
| Placebo | -2.4 | ± 1.00 |
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 91.43 | |
| 15 mg Tirzepatide | 92.65 | |
| Placebo | 29.41 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -9.0 | ± 0.59 |
| 15 mg Tirzepatide | -11.1 | ± 0.61 |
| Placebo | -1.8 | ± 0.60 |
Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 70.0 | |
| 15 mg Tirzepatide | 83.82 | |
| Placebo | 14.71 |
Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 48.57 | |
| 15 mg Tirzepatide | 72.06 | |
| Placebo | 2.94 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -11.9 | ± 0.83 |
| 15 mg Tirzepatide | -16.4 | ± 0.85 |
| Placebo | -2.7 | ± 0.84 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -13.1 | ± 0.93 |
| 15 mg Tirzepatide | -18.1 | ± 0.95 |
| Placebo | -2.1 | ± 0.94 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -4.7 | ± 0.29 |
| 15 mg Tirzepatide | -6.4 | ± 0.30 |
| Placebo | -0.8 | ± 0.30 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -0.34 | ± 0.032 |
| 15 mg Tirzepatide | -0.35 | ± 0.033 |
| Placebo | 0.03 | ± 0.033 |
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.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | -0.25 | ± 0.050 |
| 15 mg Tirzepatide | -0.33 | ± 0.052 |
| Placebo | 0.22 | ± 0.051 |
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 1
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 2.0 | ± 0.40 |
| 15 mg Tirzepatide | 1.9 | ± 0.42 |
| Placebo | 0.8 | ± 0.41 |
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) a
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Tirzepatide | 11.2 | ± 1.44 |
| 15 mg Tirzepatide | 12.0 | ± 1.48 |
| Placebo | 3.5 | ± 1.48 |
Time frame: Baseline Through Safety Follow-Up (Up To Week 56). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo |
|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | — | — | — |
| Chronic gastritis | Gastrointestinal disorders | — | — | — |
| Large intestine polyp | Gastrointestinal disorders | — | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — | — |
| Covid-19 | Infections and infestations | — | — | — |
| Epididymitis | Infections and infestations | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Comminuted fracture | Injury, poisoning and procedural complications | — | — | — |
| Hand fracture | Injury, poisoning and procedural complications | — | — | — |
| Gout | Metabolism and nutrition disorders | — | — | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — | — | — |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | — | — | — |
| Benign neoplasm of bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Cervical radiculopathy | Nervous system disorders | — | — | — |
| Radiculopathy | Nervous system disorders | — | — | — |
| Uterine polyp | Reproductive system and breast disorders | — | — | — |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Abortion induced | Surgical and medical procedures | — | — | — |
| Medical device removal | Surgical and medical procedures | — | — | — |
| Reaction | System | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Gingivitis | Infections and infestations | — | — | — |
| Amylase increased | Investigations | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Injection site reaction | General disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Vaginal infection | Infections and infestations | — | — | — |
| Abortion induced | Surgical and medical procedures | — | — | — |
| Menstruation irregular | Reproductive system and breast disorders | — | — | — |
Most-reported serious reactions: Supraventricular tachycardia, Chronic gastritis, Large intestine polyp, Cholecystitis acute, Covid-19, Epididymitis, Urinary tract infection, Comminuted fracture.
Data from ClinicalTrials.gov NCT05024032 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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