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84 Participants NeededMy employer runs this trial

ASC35 Injection for Weight Management

AR
Overseen ByAscletis Recruiting
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ascletis Pharma (China) Co., Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity and want to manage their weight. Participants should generally be in good health aside from their weight issues. Specific inclusion and exclusion criteria apply, but details are not provided here.

Inclusion Criteria

Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site
No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures
I am between 18 and 65 years old.

Exclusion Criteria

Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol
I do not have any serious active or long-term illnesses.
I have an autoimmune disease or a weakened immune system.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • ASC35 Injection B
  • Tirzepatide

Trial Overview

The study tests different doses of a new injection called ASC35 compared to a placebo (inactive shot) and Tirzepatide, an existing medication. Injections are given under the skin, with participants randomly assigned to groups without knowing which treatment they get.

How Is the Trial Designed?

9

Treatment groups

Experimental Treatment

Active Control

Group I: SAD Cohort 4Experimental Treatment2 Interventions
Group II: SAD Cohort 3Experimental Treatment2 Interventions
Group III: SAD Cohort 2Experimental Treatment2 Interventions
Group IV: SAD Cohort 1Experimental Treatment2 Interventions
Group V: MAD Cohort 4Experimental Treatment2 Interventions
Group VI: MAD Cohort 3Experimental Treatment2 Interventions
Group VII: MAD Cohort 2Experimental Treatment2 Interventions
Group VIII: MAD Cohort 1Experimental Treatment2 Interventions
Group IX: MAD Cohort 0Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials
3
Recruited
180+

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