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

Korábbi kezelés

• Have used prescription or investigational drugs that promote weight loss within 3 months prior to the first dose of investigational product.
• Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
• Prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab).

Más betegség

• Have evidence of any clinically significant active or chronic disease.
• Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
• Presence/history of cardiovascular disease incl. stable/unstable angina, MI, TIA, stroke, cardiac decompensation, clinically significant arrhythmias or conduction disorders, per PI discretion.
• Have a lifetime history of suicide attempt.
• Participants who have any history of hypersensitivity or intolerance to amylin receptor agonists, related compounds, or drugs of similar mechanisms of action (MoA).

Laborértékek

• Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or abnormal liver enzymes as defined as follows at screening.
  • Total bilirubin > 1.5x upper limit of normal (ULN);
  • AST > 2x ULN;
  • ALT > 2x ULN.
• 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 <12 ng/mL.
  • Clinically significant magnesium, total calcium, or calcitriol levels.
• Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease)

Egyéb

• 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)
• Have poorly controlled high blood pressure per Investigator's judgment during screening:
  • systolic blood pressure (SBP) ≥160 mmHg
  • diastolic blood pressure (DBP) ≥100 mmHg

• Have provided informed consent before initiation of any study-specific procedures.
• Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
• Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to <30 kg/m2).
• Female participant is eligible to participate if she is not pregnant, breastfeeding, or planning to breastfeed, and one of the following conditions applies:
  • Is a woman of nonchildbearing potential (postmenopausal [12 months of amenorrhea with follicle-stimulating hormone level consistent with a postmenopausal state [FSH≥40 mIU/mL)]; or surgically sterile [hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation]).
  • Is a WOCBP and using a highly effective contraceptive method (see Appendix 1) starting from one month before the first dose and lasting until 6 months or 5 half lives, whichever is longer, after the last dose. WOCBP on hormonal contraceptives should be advised to also use a male condom with spermicide since IMP may reduce the efficacy of hormonal contraceptives