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On May 6, Hansoh Pharma registered aA Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Once-daily Oral HS-10501/HS-10501-2 in Overweight and Obese Subjects。
ComeSource:Official Website of Drug Clinical Trial Registration and Information Disclosure Platform
This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study aimed at evaluating the efficacy of once-daily oral administration of HS-10501 and HS- in adult subjects who are overweight with at least one weight-related comorbidity and in those who are obese.Efficacy and Safety of 10501-2.
The study plans to enroll 540 subjects, who will be randomly assigned to receiveHS-10501(5mg、20mg)、HS-10501-2(5mg、10mg), placebo treatment, once daily. The treatment duration for HS-10501 is 36 weeks,HS-10501-2 Treatment Duration is 26 Weeks.
The primary endpoint was the percentage change in body weight from baseline at Week 26.. Secondary endpoints includePercentage change in weight from baseline, absolute change in weight from baseline, proportion of participants with ≥ 5% weight loss from baseline, proportion of participants with ≥ 10% weight loss from baseline, change in BMI from baseline, change in waist circumference from baseline.Change in Systolic Blood Pressure from Baseline, Total Cholesterol(TC)etc.
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