Recruiting
Phase 1

ASC35

Sponsor:

Ascletis Pharma (China) Co., Limited

Code:

NCT07842640

Conditions

Chronic Weight Management

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ASC35 Injection B, for subcutaneous use

ASC35 Placebo Injection B, for subcutaneous use

Tirzepatide

Study Details

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 ASC35 injection

Conditions

Chronic Weight Management

Study ID

NCT07842640

Start date

Aug 27, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
  • Are between 18 and 65 years of age (both inclusive) at time of screening.
  • No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

  • Have evidence of any clinically significant active or chronic disease.
  • Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
  • Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
  • Have a history of acute or chronic pancreatitis.
  • Have a known clinically significant gastric emptying abnormality.
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
  • Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAD Cohort 1

SAD Dose 1

experimental: SAD Cohort 2

SAD Dose 2

experimental: SAD Cohort 3

SAD Dose 3

experimental: SAD Cohort 4

SAD Dose 4

active comparator: MAD Cohort 0

MAD Cohort 0

experimental: MAD Cohort 1

MAD Cohort 1

experimental: MAD Cohort 2

MAD Cohort 2

experimental: MAD Cohort 3

MAD Cohort 3

experimental: MAD Cohort 4

MAD Cohort 4

Interventions

ASC35 Injection B, for subcutaneous use

ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.

ASC35 Placebo Injection B, for subcutaneous use

ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B

Tirzepatide

Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection

Primary outcome measure

  • Adverse events [ Time Frame: Baseline and Day 141 ]

Central Contacts and Locations

Central contacts

Ascletis Recruiting

+1 2068073688clinicaltrials@ascletis.com

Locations

Ascletis Clinical Site

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

More Information

Sponsor

Ascletis Pharma (China) Co., Limited

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Ascletis Pharma (China) Co., Limited on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.