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