A Phase 1 interventional study of ASC36 Injection A, for subcutaneous use and ASC36 Placebo Injection A, for subcutaneous use in Chronic Weight Management, sponsored by Ascletis Pharma (China) Co., Limited. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 1, Interventional, and Treatment
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 Two Formulations of ASC36 injection
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 144 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Ascletis Pharma (China) Co., Limited is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participant is eligible to participate if she is not pregnant, breastfeeding, or planning to breastfeed, and one of the following conditions applies:
Exclusion Criteria:
Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or abnormal liver enzymes as defined as follows at screening.
Have an electrocardiogram (ECG) abnormality at screening as defined as follows:
Have poorly controlled high blood pressure per Investigator's judgment during screening:
i. systolic blood pressure (SBP) ≥160 mmHg
ii. diastolic blood pressure (DBP) ≥100 mmHg
Have the following lab findings at screening:
SAD Dose 1 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
SAD Dose 2 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
SAD Dose 3 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
SAD Dose 4 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
MAD Dose 1 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
MAD Dose 2 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
MAD Dose 3 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
MAD Dose 4 for Formulation A
Drug: ASC36 Injection A, for subcutaneous use · Drug: ASC36 Placebo Injection A, for subcutaneous use
SAD Dose 1 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
SAD Dose 2 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
SAD Dose 3 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
SAD Dose 4 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
MAD Dose 1 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
MAD Dose 2 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
MAD Dose 3 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
MAD Dose 4 for Formulation B
Drug: ASC36 Injection B, for subcutaneous use · Drug: ASC36 Placebo Injection B, for subcutaneous use
ASC36 Injection A is an investigational formulation of ASC36 administered by subcutaneous injection.
ASC36 Placebo Injection A is an placebo injection matching ASC36 Injection A.
ASC36 Injection B is an investigational formulation of ASC36 administered by subcutaneous injection.
ASC36 Placebo Injection B is an placebo injection matching ASC36 Injection B.
Adverse Events
A summary of AEs, SAEs, and other non-serious adverse events following single SC doses of ASC36 injection
Time frame: From baseline to the end of treatment (up to 16 weeks or Day 113)
Adverse Events
A summary of AEs, SAEs, and other non-serious adverse events following multiple SC doses of ASC36 injection
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Cmax of ASC36 Injection
Evaluate the peak plasma concentration of ASC36 Injection
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Tmax of ASC36 Injection
Evaluate the time to reach peak plasma concentration of ASC36 Injection
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
AUC of ASC36 Injection
Evaluate the area under the plasma concentration-time curve of ASC36 Injection
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Half-life of ASC36 Injection
Evaluate the time required for the plasma concentration of ASC36 to decrease by 50%
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Percent Change From Baseline in Body Weight
Percent Change From Baseline in Body Weight
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Percent Change From Baseline in Waist Circumference
Percent Change From Baseline in Waist Circumference
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Percent Change From Baseline in BMI
Percent Change From Baseline in BMI
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Immunogenicity of ASC36 Injections
Incidence and prevalence of treatment-emergent antidrug antibodies against ASC36 after SC doses of ASC36 injection
Time frame: From baseline to the end of treatment (up to 20 weeks or Day 141)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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