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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Ascletis Pharma (China) Co., Limited
Study ID
NCT07842640
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Weight Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ASC35 Injection B, for subcutaneous use — DRUG
    ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.
  • ASC35 Placebo Injection B, for subcutaneous use — DRUG
    ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
  • 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

Study Details

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

Key Dates

First listed
Sep 25, 2026
Start date
Aug 27, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Adverse events [ Time Frame: Baseline and Day 141 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ascletis Clinical SiteBaltimoreMaryland21201
Ascletis Recruiting
[email protected]

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By research site
Ascletis Clinical Site· Baltimore, MD

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