Table 4 Efficacy findings from randomization (week 0) to week 72

From: Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial

 

LSM (s.e.)

Treatment comparison

Tirzepatide MTD (n = 287)

Placebo (n = 292)

Difference from placebo (95% CI)

P value

Primary endpoints

Per cent change in body weight

−18.4 (0.7)

2.5 (1.0)

ETD −20.8 (−23.2, −18.5)

<0.001

Participants achieving ≥5% body weight reduction, %

87.5 (2.2)

16.5 (3.0)

OR 34.6 (19.2, 62.6)

<0.001

Key secondary endpoints

Participants achieving body weight reduction, %

 ≥10%

76.7 (2.7)

8.9 (2.4)

OR 34.7 (17.6, 68.3)

<0.001

 ≥15%

65.4 (3.0)

4.2 (1.8)

OR 48.2 (19.2, 121.0)

<0.001

 ≥20%

44.7 (3.0)

2.2 (1.3)

OR 40.4 (12.2, 133.8)

<0.001

Participants maintaining ≥80% of lead-in body weight lost at week 72, %

94.0 (1.7)

43.8 (3.9)

ETD 19.7 (10.3, 37.6)

<0.001

Change in waist circumference, cm

−14.6 (0.7)

0.2 (1.0)

ETD −14.8 (−17.2, −12.5)

<0.001

Additional secondary endpoints

Change in body weight, kg

−21.5 (0.7)

3.5 (0.7)

ETD −25.0 (−26.9, −23.2)

NRa

Change in BMI, kg/m2

−7.7 (0.2)

1.2 (0.2)

ETD −8.9 (−9.6, −8.3)

NR

Change in SBP, mmHg

−5.1 (0.7)

4.1 (0.7)

ETD −9.2 (−11.2, −7.2)

NR

Change in DBP, mmHg

−3.2 (0.5)

2.3 (0.5)

ETD –5.5 (−6.9, −4.1)

NR

Fasting lipids

 Per cent change in total cholesterol

−3.0 (1.0)

5.2 (1.1)

ETD −7.8 (−10.4, −5.1)

NR

 Per cent change in non-HDL cholesterol

−9.8 (1.3)

5.6 (1.5)

ETD −14.6 (−17.9, −11.2)

NR

 Per cent change in HDL cholesterol

15.4 (1.2)

3.6 (1.1)

ETD 11.4 (8.2, 14.7)

NR

 Per cent change in LDL cholesterol

−6.1 (1.4)

6.1 (1.7)

ETD −11.5 (−15.3, −7.5)

NR

 Per cent change in VLDL cholesterol

−25.6 (1.6)

3.0 (2.3)

ETD −27.8 (−32.1, −23.2)

NR

 Per cent change in triglycerides

−25.8 (1.6)

3.0 (2.3)

ETD −28.0 (−32.3, −23.4)

NR

 Per cent change in free fatty acids

−33.1 (2.2)

−15.0 (3.0)

ETD −21.3 (−28.4, −13.6)

NR

Change in fasting glucose, mg dl−1

−8.8 (0.8)

2.4 (0.9)

ETD −11.2 (−13.5, −8.8)

NR

Change in HbA1c, %

−0.5 (0.0)

0.0 (0.0)

ETD −0.5 (−0.5, −0.4)

NR

Per cent change in fasting insulin

−39.1 (2.5)

17.3 (5.0)

ETD −48.1 (−53.7, −41.7)

NR

Patient-reported outcomes

 Change in SF-36v2 Physical Functioning domain scoreb

3.3 (0.4)

−0.6 (0.4)

ETD 3.9 (2.8, 4.9)

NR

 Change in IWQOL-Lite-CT Physical Function composite scorec

13.9 (1.1)

1.1 (1.2)

ETD 12.8 (9.7, 16.0)

NR

Prespecified exploratory endpoints

 Participants achieving body weight reduction ≥25%, %

28.7 (2.7)

1.2 (0.9)

OR 33.70 (8.84, 128.52)

NR

  1. Primary, key secondary and prespecified exploratory endpoints are presented using the TRE, and additional secondary endpoints are presented using the efficacy estimand. Primary and key secondary endpoints were controlled for type 1 error at a two-sided significance level of 0.05 within each estimand via a graphical testing approach. Other endpoints were not controlled for type 1 error.
  2. DBP, diastolic blood pressure; ETD, estimated treatment difference; NR, not reported; SBP, systolic blood pressure.
  3. aP values are not reported for additional secondary and prespecified exploratory endpoints because these were not controlled for type 1 error.
  4. bSF-36v2 measures health-related quality of life and general health status. SF-36v2 scores are norm based—that is, transformed to a scale in which the 2009 US general population has a mean score of 50 and s.d. of 10. An increase in score represents an improvement in health status.
  5. cIWQOL-Lite-CT measures weight-specific, health-related quality of life. All items are rated on either a five-point frequency scale (‘never’ to ‘always’) or a five-point truth scale (‘not at all true’ to ‘completely true’). Scores are transformed to a scale of 0–100, with higher scores reflecting better levels of functioning.
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