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RecruitingNCT07842640Updated Sep 25, 2026

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

A Phase 1 interventional study of ASC35 Injection B, for subcutaneous use and ASC35 Placebo Injection B, for subcutaneous use in Chronic Weight Management, sponsored by Ascletis Pharma (China) Co., Limited. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Ascletis Pharma (China) Co., Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Weight Management
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    SAD Cohort 1

    SAD Dose 1

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

  • Experimental
    SAD Cohort 2

    SAD Dose 2

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

  • Experimental
    SAD Cohort 3

    SAD Dose 3

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

  • Experimental
    SAD Cohort 4

    SAD Dose 4

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

  • Active comparator
    MAD Cohort 0

    MAD Cohort 0

    Drug: Tirzepatide

  • Experimental
    MAD Cohort 1

    MAD Cohort 1

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

  • Experimental
    MAD Cohort 2

    MAD Cohort 2

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

  • Experimental
    MAD Cohort 3

    MAD Cohort 3

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

  • Experimental
    MAD Cohort 4

    MAD Cohort 4

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

Interventions

  • DrugASC35 Injection B, for subcutaneous use

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

  • DrugASC35 Placebo Injection B, for subcutaneous use

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

  • DrugTirzepatide

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

05

What researchers measure

Primary outcomes

  1. Adverse events

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

    Time frame: Baseline and Day 141

Secondary outcomes

  1. Cmax of ASC35

    Evaluate the peak plasma concentration of ASC35

    Time frame: Baseline and Day 141

  2. Tmax of ASC35

    Evaluate the time to reach peak plasma concentration of ASC35

    Time frame: Baseline and Day 141

  3. AUC of ASC35

    Evaluate the area under the plasma concentration-time curve of ASC35

    Time frame: Baseline and Day 141

  4. Change From Baseline in Body Weight

    Percentage Change From Baseline in Body Weight

    Time frame: Baseline and Day 141

  5. Change From Baseline in Body Weight

    Actual Change From Baseline in Body Weight

    Time frame: Baseline and Day 141

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07842640
Lead sponsor
Ascletis Pharma (China) Co., Limited
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Aug 27, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Ascletis Recruiting
Contact
clinicaltrials@ascletis.com
+1 2068073688

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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