The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2 or C6), or once weekly for up to 24 weeks (Cohort C3, C4 and C5), including a dose escalation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
oral tablets
oral tablets
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe incidence and severity of adverse events
Time frame: up to day 204
Pharmacokinetics of oral ecnoglutide tablet
Cmax, Tmax and AUC
Time frame: up to day 204
Change of body weight from baseline
Time frame: up to day 204
Change of BMI from baseline
Time frame: up to day 204
Change of waist circumference from baseline
Time frame: up to day 204
Change of hip circumference from baseline
Time frame: up to day 204
Change of neck circumference from baseline
Time frame: up to day 204
Change of waist/hip ratio from baseline
Time frame: up to day 204
Change of fasting blood glucose from baseline
Time frame: up to day 204
Change of fasting insulin from baseline
Time frame: up to day 204
Change of lipid profile from baseline
Time frame: up to day 204
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