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

ConditionChronic Weight Management
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAscletis Pharma (China) Co., Limited

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

84 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: SAD Cohort 1Experimental treatment 2 interventions
Group B: SAD Cohort 2Experimental treatment 2 interventions
Group C: SAD Cohort 3Experimental treatment 2 interventions
Group D: SAD Cohort 4Experimental treatment 2 interventions
Group E: MAD Cohort 0Active comparator 1 intervention
Group F: MAD Cohort 1Experimental treatment 2 interventions
Group G: MAD Cohort 2Experimental treatment 2 interventions
Group H: MAD Cohort 3Experimental treatment 2 interventions
Group I: MAD Cohort 4Experimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascletis Pharma (China) Co., Limited

Lead sponsor

Source ClinicalTrials.gov
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