ASC36A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection in Participants With Obesity or Overweight

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 <30 kg/m2).
4. 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:

1. Have evidence of any clinically significant active or chronic disease.
2. 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.
3. Have used prescription or investigational drugs that promote weight loss within 3 months prior to the first dose of investigational product.
4. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
5. Presence/history of cardiovascular disease incl. stable/unstable angina, MI, TIA, stroke, cardiac decompensation, clinically significant arrhythmias or conduction disorders, per PI discretion.
6. Have a lifetime history of suicide attempt.
7. Participants who have any history of hypersensitivity or intolerance to amylin receptor agonists, related compounds, or drugs of similar mechanisms of action (MoA).
8. 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.

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 <12 ng/mL.
• Clinically significant magnesium, total calcium, or calcitriol levels.

12. Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease)
13. Prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab).