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

NCT07842640 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ASC35-101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  A summary of AEs, SAEs and other non-serious adverse events

  Baseline and Day 141

Secondary Outcomes (5)

• Cmax of ASC35

  Baseline and Day 141

• Tmax of ASC35

  Baseline and Day 141

• AUC of ASC35

  Baseline and Day 141

• Change From Baseline in Body Weight

  Baseline and Day 141

• Change From Baseline in Body Weight

  Baseline and Day 141

Study Arms (9)

SAD Cohort 1

EXPERIMENTAL

SAD Dose 1

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

SAD Cohort 2

EXPERIMENTAL

SAD Dose 2

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

SAD Cohort 3

EXPERIMENTAL

SAD Dose 3

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

SAD Cohort 4

EXPERIMENTAL

SAD Dose 4

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

MAD Cohort 0

ACTIVE COMPARATOR

MAD Cohort 0

Drug: Tirzepatide

MAD Cohort 1

EXPERIMENTAL

MAD Cohort 1

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

MAD Cohort 2

EXPERIMENTAL

MAD Cohort 2

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

MAD Cohort 3

EXPERIMENTAL

MAD Cohort 3

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

MAD Cohort 4

EXPERIMENTAL

MAD Cohort 4

Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use

Interventions

ASC35 Injection B, for subcutaneous use DRUG

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

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; MAD Cohort 4; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4

ASC35 Placebo Injection B, for subcutaneous use DRUG

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

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; MAD Cohort 4; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4

Tirzepatide DRUG

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

MAD Cohort 0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ascletis Clinical Site

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

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: September 21, 2026
• First Posted: September 25, 2026
• Study Start: August 27, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)