Tests ASC36 tablets for safety in adults with obesity or overweight

Trial details

Who runs it

Ascletis Pharma (China) Co., Limited

Trial code

NCT07893106

Record updated

23 October 2026

Original description

This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or OverweightRead full original descriptionShow less

A Phase I, Randomized, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Are Overweight

This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight

Inclusion: 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) at screening; 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≥30 mIU/mL)]; or surgically sterile [hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation]); Is a WOCBP and agrees to use a highly effective contraceptive method (heterosexual abstinence as a lifestyle, or a male condom in conjunction with a second method of contraception that is one of the following: established combined estrogen and/or progesterone hormonal contraception (e.g. oral contraceptive pill), depot injection, contraceptive implant, or intra-uterine device) and refrain from donating egg starting from one month before the first dose and lasting until 6 months or 5 half lives, whichever is longer, after the last dose.

Exclusion: Have used prescription drugs that promote weight loss within 6 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; Has had prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab); Have evidence of any clinically significant active or chronic disease (with the exception of obesity or overweight); 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; 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 > 1.5x ULN; ALT > 1.5x ULN; Have abnormal values in calcitonin, magnesium, parathyroid hormone (PTH), vitamin D (25-hydroxycholecalciferol), and calcitriol per Investigator discretion; Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease) per Investigator discretion; Have an electrocardiogram (ECG) abnormality at screening as defined as follows:; QTcF interval > 450 ms (male) or 470 ms (female); PR (PQ) interval prolongation (> 200 ms); Intermittent second or third-degree AV block, or AV dissociation; Right bundle branch block (RBBB), left bundle branch block (LBBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) (defined as QRS duration >120 ms); Elevated resting pulse rate (>100 bpm); Have poorly controlled high blood pressure per Investigator's judgment during screening.

ClinicalTrials.gov NCT07893106