Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07893093

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection in Participants With Obesity or Overweight

Conditions: Chronic Weight Management

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 144
Sponsor: Ascletis Pharma (China) Co., Limited

Location: Ascletis Clinical Site San Antonio Texas

Summary

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 Two Formulations of ASC36 injection

Eligibility Criteria

Inclusion Criteria: 1. Have provided informed consent before initiation of any study-specific procedures. 2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive). 3. Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to \ 1.5x upper limit of normal (ULN); * AST \> 2x ULN; * ALT \> 2x ULN. 9. Have an electrocardiogram (ECG) abnormality at screening as defined as follows: * QTcF interval \> 450 ms (male) or 470 ms (female) * PR (PQ) interval prolongation (\> 230 ms) * Intermittent second or third-degree AV block, or AV dissociation * Right Bundle Branch Block (RBBB), left bundle branch block (LBBB), and QRS interval \>120 ms. * Elevated resting pulse rate (\>100 bpm) 10. Have poorly controlled high blood pressure per Investigator's judgment during screening: i. systolic blood pressure (SBP) ≥160 mmHg ii. diastolic blood pressure (DBP) ≥100 mmHg 11. Have the following lab findings at screening: * Calcitonin level ≥50 ng/L at screening. * Parathyroid hormone (PTH) level outside the reference range. * Vitamin D (25-hydroxycholecalciferol) level \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07893093). StuddyBuddy aggregates publicly available trial information.