LivingGLP1
parallel randomized trial

NCT04969627

Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.

Polycystic ovary syndromeNCT04969627S000659

Design

Randomized
60
Start year
2021
Treatment
12 weeks, follow-up 12 weeks
Countries
China (1 sites)
Sponsor
Shengjing Hospital of China Medical University (non industry)
Eligibility
age 18 to 40; Rotterdam PCOS phenotype B; BMI 24 or more

Conduct and analysis

Blinding
open label
Sequence generation
computer
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
completers
Missing data
none

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Standard care or no added treatment
Metformin (MET)
metformin 1000 mg BID; lifestyle: standard3025
A2Liraglutide 1.2 mg subcutaneous once daily
Metformin plus liraglutide (COM)
metformin 1000 mg BID; lifestyle: standard3027

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticStandard care or no added treatment
A1
Liraglutide 1.2 mg subcutaneous once daily
A2
agemean (years)23.5225.85
agesd (years)4.654.45
bmimean (kg/m2)28.8029.69
bmisd (kg/m2)4.253.44
waistmean (cm)91.9695.69
waistsd (cm)12.098.94
weightmean (kg)76.5079.09
weightsd (kg)12.448.46

Analyses this trial contributes to

Results

4 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / not stated; other; R0025102:Results
A2events0 / not stated; other; R0025102:Results
Regular menstrual cycles (2 lines; O90B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
12A1responders22 / 25not stated; completers; R0025102:Table 2
12A2responders25 / 27not stated; completers; R0025102:Table 2