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

NCT07893093 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ASC36i-101
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Chronic Weight Management

Keywords

Chronic Weight Management; Obesity; Amylin receptor

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  A summary of AEs, SAEs, and other non-serious adverse events following single SC doses of ASC36 injection

  From baseline to the end of treatment (up to 16 weeks or Day 113)

• Adverse Events

  A summary of AEs, SAEs, and other non-serious adverse events following multiple SC doses of ASC36 injection

  From baseline to the end of treatment (up to 20 weeks or Day 141)

Secondary Outcomes (8)

• Cmax of ASC36 Injection

  From baseline to the end of treatment (up to 20 weeks or Day 141)

• Tmax of ASC36 Injection

  From baseline to the end of treatment (up to 20 weeks or Day 141)

• AUC of ASC36 Injection

  From baseline to the end of treatment (up to 20 weeks or Day 141)

• Half-life of ASC36 Injection

  From baseline to the end of treatment (up to 20 weeks or Day 141)

• Percent Change From Baseline in Body Weight

  From baseline to the end of treatment (up to 20 weeks or Day 141)

Study Arms (16)

Section 1 Part 1 (SAD) Cohort 1

EXPERIMENTAL

SAD Dose 1 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 1 (SAD) Cohort 2

EXPERIMENTAL

SAD Dose 2 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 1 (SAD) Cohort 3

EXPERIMENTAL

SAD Dose 3 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 1 (SAD) Cohort 4

EXPERIMENTAL

SAD Dose 4 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 2 (MAD) Cohort 1

EXPERIMENTAL

MAD Dose 1 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 2 (MAD) Cohort 2

EXPERIMENTAL

MAD Dose 2 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 2 (MAD) Cohort 3

EXPERIMENTAL

MAD Dose 3 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 1 Part 2 (MAD) Cohort 4

EXPERIMENTAL

MAD Dose 4 for Formulation A

Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use

Section 2 Part 1 (SAD) Cohort 1

EXPERIMENTAL

SAD Dose 1 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 1 (SAD) Cohort 2

EXPERIMENTAL

SAD Dose 2 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 1 (SAD) Cohort 3

EXPERIMENTAL

SAD Dose 3 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 1 (SAD) Cohort 4

EXPERIMENTAL

SAD Dose 4 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 2 (MAD) Cohort 1

EXPERIMENTAL

MAD Dose 1 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 2 (MAD) Cohort 2

EXPERIMENTAL

MAD Dose 2 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 2 (MAD) Cohort 3

EXPERIMENTAL

MAD Dose 3 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Section 2 Part 2 (MAD) Cohort 4

EXPERIMENTAL

MAD Dose 4 for Formulation B

Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use

Interventions

ASC36 Injection A, for subcutaneous use DRUG

ASC36 Injection A is an investigational formulation of ASC36 administered by subcutaneous injection.

Section 1 Part 1 (SAD) Cohort 1; Section 1 Part 1 (SAD) Cohort 2; Section 1 Part 1 (SAD) Cohort 3; Section 1 Part 1 (SAD) Cohort 4; Section 1 Part 2 (MAD) Cohort 1; Section 1 Part 2 (MAD) Cohort 2; Section 1 Part 2 (MAD) Cohort 3; Section 1 Part 2 (MAD) Cohort 4

ASC36 Placebo Injection A, for subcutaneous use DRUG

ASC36 Placebo Injection A is an placebo injection matching ASC36 Injection A.

Section 1 Part 1 (SAD) Cohort 1; Section 1 Part 1 (SAD) Cohort 2; Section 1 Part 1 (SAD) Cohort 3; Section 1 Part 1 (SAD) Cohort 4; Section 1 Part 2 (MAD) Cohort 1; Section 1 Part 2 (MAD) Cohort 2; Section 1 Part 2 (MAD) Cohort 3; Section 1 Part 2 (MAD) Cohort 4

ASC36 Injection B, for subcutaneous use DRUG

ASC36 Injection B is an investigational formulation of ASC36 administered by subcutaneous injection.

Section 2 Part 1 (SAD) Cohort 1; Section 2 Part 1 (SAD) Cohort 2; Section 2 Part 1 (SAD) Cohort 3; Section 2 Part 1 (SAD) Cohort 4; Section 2 Part 2 (MAD) Cohort 1; Section 2 Part 2 (MAD) Cohort 2; Section 2 Part 2 (MAD) Cohort 3; Section 2 Part 2 (MAD) Cohort 4

ASC36 Placebo Injection B, for subcutaneous use DRUG

ASC36 Placebo Injection B is an placebo injection matching ASC36 Injection B.

Section 2 Part 1 (SAD) Cohort 1; Section 2 Part 1 (SAD) Cohort 2; Section 2 Part 1 (SAD) Cohort 3; Section 2 Part 1 (SAD) Cohort 4; Section 2 Part 2 (MAD) Cohort 1; Section 2 Part 2 (MAD) Cohort 2; Section 2 Part 2 (MAD) Cohort 3; Section 2 Part 2 (MAD) Cohort 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (2)

Ascletis Clinical Site

San Antonio, Texas, 78232, United States

RECRUITING

Ascletis Clinical Site

Salt Lake City, Utah, 84124, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ascletis Recruiting

CONTACT

+1 2068073688; clinicaltrials@ascletis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)