A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight

A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Weight Management
• Intervention / Treatment: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use; Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ascletis Recruiting; Phone Number: +1 2068073688; Email: clinicaltrials@ascletis.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Ascletis Clinical Site
      • Contact: Ascletis Recruiting; Email: clinicaltrials@ascletis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohort 1; SAD Dose 1	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: SAD Cohort 2; SAD Dose 2	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: SAD Cohort 3; SAD Dose 3	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: SAD Cohort 4; SAD Dose 4	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Active Comparator: MAD Cohort 0; MAD Cohort 0	Drug: 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
Experimental: MAD Cohort 1; MAD Cohort 1	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: MAD Cohort 2; MAD Cohort 2	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: MAD Cohort 3; MAD Cohort 3	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
Experimental: MAD Cohort 4; MAD Cohort 4	Drug: ASC35 Injection B, for subcutaneous use; ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.; Drug: ASC35 Placebo Injection B, for subcutaneous use; ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	A summary of AEs, SAEs and other non-serious adverse events	Baseline and Day 141

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of ASC35	Evaluate the peak plasma concentration of ASC35	Baseline and Day 141
Tmax of ASC35	Evaluate the time to reach peak plasma concentration of ASC35	Baseline and Day 141
AUC of ASC35	Evaluate the area under the plasma concentration-time curve of ASC35	Baseline and Day 141
Change From Baseline in Body Weight	Percentage Change From Baseline in Body Weight	Baseline and Day 141
Change From Baseline in Body Weight	Actual Change From Baseline in Body Weight	Baseline and Day 141

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 21, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): September 25, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: ASC35-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No