Table 2 Changes in body weight and waist circumference, and proportion of participants achieving weight loss targets at week 24

From: A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity

 

Mazdutide 3 mg (n = 62)

Mazdutide 4.5 mg (n = 63)

Mazdutide 6 mg (n = 61)

Placebo (n = 62)

Mean

p

Mean

p

Mean

p

Mean

Primary endpoint - Percentage change from baseline in body weight (primary analysis – ANCOVA + LOCF)

Percentage change, %

−6.7 (0.7)

 

−10.4 (0.7)

 

−11.3 (0.7)

 

1.0 (0.7)

  ETD versus placebo

−7.7 (−9.5, −5.9)

<0.0001

−11.4 (−13.2, −9.6)

<0.0001

−12.3 (−14.1, −10.5)

<0.0001

 

Secondary endpoints

Proportion of participants achieving

   ≥5% weight loss, n (%)

36 (58.1)

 

52 (82.5)

 

49 (80.3)

 

3 (4.8)

    ETD versus placebo, %

53.2 (39.9, 66.5)

<0.0001

77.3 (66.4, 88.1)

<0.0001

75.1 (63.7, 86.5)

<0.0001

 

   ≥10% weight loss, n (%)

12 (19.4)

 

31 (49.2)

 

31 (50.8)

 

0

    ETD versus placebo, %

19.4 (9.5, 29.2)

0.0003

48.9 (36.5, 61.3)

<0.0001

50.1 (37.5, 62.8)

<0.0001

 

   ≥15% weight loss, n (%)

6 (9.7)

 

10 (15.9)

 

16 (26.2)

 

0

    ETD versus placebo, %

9.7 (2.3, 17.0)

0.0125

15.7 (6.7, 24.6)

0.0013

25.4 (14.4, 36.4)

<0.0001

 

Change from baseline in body weight, kg

−6.4 (0.6)

 

−9.1 (0.6)

 

−9.9 (0.6)

 

1.1 (0.6)

   ETD versus placebo

−7.4 (−9.0, −5.9)

<0.0001

−10.2 (−11.7, −8.6)

<0.0001

−10.9 (−12.5, −9.4)

<0.0001

 

Change from baseline in BMI, kg/m2

−2.3 (0.2)

 

−3.3 (0.2)

 

−3.6 (0.2)

 

0.4 (0.2)

   ETD versus placebo

−2.7 (−3.2, −2.1)

<0.0001

−3.7 (−4.2, −3.1)

<0.0001

−4.0 (−4.6, −3.4)

<0.0001

 

Change from baseline in waist circumference, cm

−5.6 (0.7)

 

−8.5 (0.7)

 

−8.8 (0.7)

 

−1.1 (0.7)

 ETD versus placebo

−4.5 (−6.5, −2.4)

<0.0001

−7.3 (−9.3, −5.3)

<0.0001

−7.6 (−9.6, −5.6)

<0.0001

 
  1. For continuous variables, data are LSM (SE) for change and percentage change from baseline and LSM (95% CI) for ETD, from MMRM (secondary endpoints) or ANCOVA (primary endpoint) analysis, mITT population. For categorical varibles, data are n (%) and ETD (95% CI) from Mantel-Haenszel analysis, mITT population. Proportion of participants reaching weight loss targets (≥5%, ≥10% and ≥15%) was obtained by dividing the number of participants reaching respective targets at week 24 by the number of participants with baseline value and at least one non-missing post-baseline value. Participants with missing value at week 24 were treated as non-responders. All statistical tests were two-sided at a significance level of 0.05, and no adjustments were made for multiplicity. P values were nominal except for those of the primary analysis for the primary endpoint.
  2. ANCOVA analysis of covariate, ETD estimated treatment difference, LOCF last observation carried forward, LSM least squares mean, MMRM mixed model repeated measures.
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