A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
Recruiting
Phase 1Interventional Study
Chronic Weight Management
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Ascletis Pharma (China) Co., Limited · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who are overweight or obese. Participants will receive an injection of a study drug and will be monitored for safety and how their body processes the drug.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesType 2 diabetesPancreatitis
You may be able to join if
I am between 18 and 65 years old.
I have given written consent to participate.
I have no significant health issues based on medical history and exams.
You may not be able to join if
I have a serious active or chronic disease.
I have been diagnosed with diabetes.
I have an autoimmune disease or I am immunocompromised.
I have a history of pancreatitis.
I have a known problem with how my stomach empties.
I have had an active or untreated cancer.
I have a history of severe substance abuse or eating disorders.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Eligibility Criteria
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.
* Are between 18 and 65 years of age (both inclusive) at time of screening.
* No clinically significant fin…
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.
* Are between 18 and 65 years of age (both inclusive) at time of screening.
* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion Criteria:
* Have evidence of any clinically significant active or chronic disease.
* Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have a history of acute or chronic pancreatitis.
* Have a known clinically significant gastric emptying abnormality.
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
* 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.
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