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

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.
• 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).
• 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 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:

i. systolic blood pressure (SBP) ≥160 mmHg

ii. diastolic blood pressure (DBP) ≥100 mmHg

• 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)
• Prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab).