Percent Change From Baseline in Body Weight (Primary Treatment Period)
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -2.4 | 0.40 |
| 5 mg Tirzepatide | -16.0 | 0.39 |
| 10 mg Tirzepatide | -21.4 | 0.39 |
| 15 mg Tirzepatide | -22.5 | 0.39 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name SURMOUNT-1
United States, Argentina, Brazil, China, India, Japan, Mexico, Puerto Rico, Russia, Taiwan
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
Placebo comparator
Placebo
* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.
Experimental
5 mg Tirzepatide
* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.
Experimental
10 mg Tirzepatide
* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.
Experimental
15 mg Tirzepatide
* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period.
Outcomes the sponsor listed as primary.
Percent Change From Baseline in Body Weight (Primary Treatment Period)
Time frame · Baseline, Week 72
Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period)
Time frame · Week 72
Percentage of participants who achieve greater than or equal to( ≥) 5% body weight reduction.
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 20
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period)
Time frame · Week 72
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period)
Time frame · Week 72
Percentage of participants who achieve ≥15% body weight reduction.
Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period)
Time frame · Week 72
Percentage of participants who achieve ≥20% body weight reduction.
Change From Baseline in Waist Circumference (Primary Treatment Period)
Time frame · Baseline, Week 72
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization)
Time frame · Baseline, Week 176
LS Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 176 (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Time frame · Baseline through Week 176
The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported. Time to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.
Percentage of Participants With Onset of Type 2 Diabetes From Baseline to Week 193 (Primary and Additional Treatment Periods + Safety Follow-up Period: Participants With Prediabetes at Randomization)
Time frame · Baseline through Week 193
The percentage of participants with onset of Type 2 diabetes mellitus (T2DM), evaluated as time to onset of T2DM among those who had pre-diabetes at randomization, was reported. Time to onset of Type 2 diabetes mellitus was defined as the duration from the date of randomization to the adjudication committee-confirmed date of incident diabetes. Participants who did not experience the event were censored.
Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period
Time frame · Baseline, Week 72
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period
Time frame · Baseline, Week 72
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Fasting Glucose (Primary Treatment Period)
Time frame · Baseline, Week 72
LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) - Primary Treatment Period
Time frame · Baseline, Week 72
Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -2.4 | 0.40 |
| 5 mg Tirzepatide | -16.0 | 0.39 |
| 10 mg Tirzepatide | -21.4 | 0.39 |
| 15 mg Tirzepatide | -22.5 | 0.39 |
| Group | Value (Percentage of Participants) |
|---|---|
| Placebo | 27.87 |
| 5 mg Tirzepatide | 89.41 |
| 10 mg Tirzepatide | 96.18 |
| 15 mg Tirzepatide | 96.32 |
| Group | Value (kilograms) | Spread |
|---|---|---|
| Placebo | -2.5 | 0.22 |
| Pooled 10 mg/15 mg Tirzepatide | -13.2 | 0.16 |
| Group | Value (Percentage of Participants) |
|---|---|
| Placebo | 13.54 |
| 5 mg Tirzepatide | 73.35 |
| 10 mg Tirzepatide | 85.85 |
| 15 mg Tirzepatide | 90.08 |
| Group | Value (Percentage of Participants) |
|---|---|
| Placebo | 5.98 |
| 5 mg Tirzepatide | 50.24 |
| 10 mg Tirzepatide | 73.61 |
| 15 mg Tirzepatide | 78.24 |
| Group | Value (Percentage of Participants) |
|---|---|
| Placebo | 1.26 |
| 5 mg Tirzepatide | 31.62 |
| 10 mg Tirzepatide | 55.48 |
| 15 mg Tirzepatide | 62.88 |
| Group | Value (centimeters) | Spread |
|---|---|---|
| Placebo | -3.4 | 0.42 |
| 5 mg Tirzepatide | -14.6 | 0.41 |
| 10 mg Tirzepatide | -19.4 | 0.41 |
| 15 mg Tirzepatide | -19.9 | 0.41 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Placebo | 1.7 | 0.27 |
| Pooled 10 mg/15 mg Tirzepatide | 4.0 | 0.18 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of a matching placebo, administered over a period of 72 weeks. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period. | 4 / 643 | 53 / 643 | 315 / 643 |
| 5 mg Tirzepatide* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 5 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period. | 4 / 630 | 57 / 630 | 443 / 630 |
| 10 mg Tirzepatide* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period. | 3 / 636 | 60 / 636 | 451 / 636 |
| 15 mg Tirzepatide* Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirzepatide dose SC QW until week 176. * Safety Follow-up Period: Participants who had completed or discontinued the primary treatment period were followed for safety for 4 weeks (weeks 72 - week 76), and those who had completed or discontinued the additional treatment period (prediabetes at randomization) were followed for 17 weeks (week 176 - week 193). No treatment was administered during this period. | 2 / 630 | 50 / 630 | 429 / 630 |
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
Studies that cite this trial.
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