ASC47 + Semaglutide for Weight Management

Overseen By Yvonne Li, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ascletis Pharma (China) Co., Limited

Disqualifiers: Obesity, Malignancy, Alcohol, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.

Eligibility Criteria

This trial is for non-pregnant, non-breastfeeding females who agree to use contraception and have had a stable body weight with no significant medical findings recently. It excludes those with autoimmune diseases, recent drug or alcohol abuse, obesity due to medical causes like hypothyroidism or Cushing syndrome, and anyone with a history of significant malignancy in the last 5 years.

Inclusion Criteria

I am not pregnant or breastfeeding and won't be for 6 months, and I agree to use birth control.

Subject have provided informed consent before initiation of any study specific procedures

Stable body weight (less than 5% self-reported change within the previous 3 months)

Exclusion Criteria

Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised

Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year

My obesity is due to a medical condition like a genetic disorder or hormonal imbalance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ASC47 in combination with semaglutide

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ASC47

Trial Overview The study tests ASC47 combined with Semaglutide against a placebo plus Semaglutide for weight management. It's phase I, randomized, double-blind and placebo-controlled involving screening, treatment periods and follow-up.

Participant Groups

Group I: Combo Cohort 3 in participants with obesity Experimental Treatment 2 Interventions

Cohort 3, dose 3

Group II: Combo Cohort 2 in participants with obesity Experimental Treatment 2 Interventions

Cohort 2, dose 2

Group III: Combo Cohort 1 in participants with obesity Experimental Treatment 2 Interventions

Cohort 1, dose 1

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials

3

Recruited

180+