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RecruitingPhase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight

A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ASC35 shots in adults ages 18 to 65 with obesity or overweight. It looks at safety, side effects, how the drug moves through the body, and how it affects the body. It compares single or repeated doses of ASC35 with a placebo, a shot with no active drug.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a written form agreeing to join the study.
  • Be 18 to 65 years old at screening.
  • Have no important health concerns found in your health history, physical exam, heart rhythm test, vital signs, or other screening tests.

Who can't join

  • Have a major current or long-term illness.
  • Have ever been diagnosed with type 1 or type 2 diabetes, or had dangerous acid buildup or an extreme high-blood-sugar state or coma.
  • Have a disease in which the body's defenses attack healthy cells, or have weakened defenses against illness.
  • Have a history of pancreatitis, which is swelling of the pancreas.
  • Have a known, important problem with how your stomach empties.
  • Have a history of active or untreated cancer, or be in remission from a major cancer, meaning its signs have lessened or disappeared.
  • Have another condition that the study doctor thinks could keep you from following or finishing the study, such as drug or alcohol abuse, an eating disorder, or another mental health disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

MD