Chronic Weight ManagementPhase 1NCT07893093
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection in Participants With Obesity or Overweight
A Phase 1 study testing ASC36 Injection A, for subcutaneous use and ASC36 Injection B, for subcutaneous use in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 2 sites in United States.
Trial 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 Two Formulations of ASC36 injection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Weight Management
- What is being tested?
- ASC36 Injection A, for subcutaneous use and ASC36 Injection B, for subcutaneous use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2026to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided informed consent before initiation of any study-specific procedures.
- Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
- Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to <30 kg/m2).
- Female participant is eligible to participate if she is not pregnant, breastfeeding, or planning to breastfeed, and one of the following conditions applies:
- Is a woman of nonchildbearing potential (postmenopausal [12 months of amenorrhea with follicle-stimulating hormone level consistent with a postmenopausal state [FSH≥40 mIU/mL)]; or surgically sterile [hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation]).
- Is a WOCBP and using a highly effective contraceptive method (see Appendix 1) starting from one month before the first dose and lasting until 6 months or 5 half lives, whichever is longer, after the last dose. WOCBP on hormonal contraceptives should be advised to also use a male condom with spermicide since IMP may reduce the efficacy of hormonal contraceptives
Who cannot join
- Have evidence of any clinically significant active or chronic disease.
- Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
- Have used prescription or investigational drugs that promote weight loss within 3 months prior to the first dose of investigational product.
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
- Presence/history of cardiovascular disease incl. stable/unstable angina, MI, TIA, stroke, cardiac decompensation, clinically significant arrhythmias or conduction disorders, per PI discretion.
- Have a lifetime history of suicide attempt.
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- Participants who have any history of hypersensitivity or intolerance to amylin receptor agonists, related compounds, or drugs of similar mechanisms of action (MoA).
- 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.
- Total bilirubin > 1.5x upper limit of normal (ULN);
- AST > 2x ULN;
- ALT > 2x ULN.
- Have an electrocardiogram (ECG) abnormality at screening as defined as follows:
- QTcF interval > 450 ms (male) or 470 ms (female)
- PR (PQ) interval prolongation (> 230 ms)
- Intermittent second or third-degree AV block, or AV dissociation
- Right Bundle Branch Block (RBBB), left bundle branch block (LBBB), and QRS interval >120 ms.
- Elevated resting pulse rate (>100 bpm)
- Have poorly controlled high blood pressure per Investigator's judgment during screening:
- systolic blood pressure (SBP) ≥160 mmHg
- diastolic blood pressure (DBP) ≥100 mmHg
- Have the following lab findings at screening:
- Calcitonin level ≥50 ng/L at screening.
- Parathyroid hormone (PTH) level outside the reference range.
- Vitamin D (25-hydroxycholecalciferol) level <12 ng/mL.
- Clinically significant magnesium, total calcium, or calcitriol levels.
- Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease)
- Prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ascletis Clinical Site
Salt Lake City, Utah, 84124
Ascletis Recruiting, clinicaltrials@ascletis.com
- Recruiting
Ascletis Clinical Site
San Antonio, Texas, 78232
Ascletis Recruiting, clinicaltrials@ascletis.com
About this study
Official title: A Phase I, Randomized, Placebo-controlled, Double-blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection for Subcutaneous Use in Adult Participants With Obesity or Are Overweight
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
- Conditions
- Chronic Weight Management
- Being tested
- ASC36 Injection A, for subcutaneous use, ASC36 Placebo Injection A, for subcutaneous use, ASC36 Injection B, for subcutaneous use, ASC36 Placebo Injection B, for subcutaneous use
- Keywords
- Chronic Weight Management, Obesity, Amylin receptor
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC36 Injection A, for subcutaneous useDrug
ASC36 Injection A is an investigational formulation of ASC36 administered by subcutaneous injection.
ASC36 Placebo Injection A, for subcutaneous useDrug
ASC36 Placebo Injection A is an placebo injection matching ASC36 Injection A.
ASC36 Injection B, for subcutaneous useDrug
ASC36 Injection B is an investigational formulation of ASC36 administered by subcutaneous injection.
ASC36 Placebo Injection B, for subcutaneous useDrug
ASC36 Placebo Injection B is an placebo injection matching ASC36 Injection B.
| Study group | Role | What they receive |
|---|---|---|
| Section 1 Part 1 (SAD) Cohort 1 | Experimental | SAD Dose 1 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 1 (SAD) Cohort 2 | Experimental | SAD Dose 2 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 1 (SAD) Cohort 3 | Experimental | SAD Dose 3 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 1 (SAD) Cohort 4 | Experimental | SAD Dose 4 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 2 (MAD) Cohort 1 | Experimental | MAD Dose 1 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 2 (MAD) Cohort 2 | Experimental | MAD Dose 2 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 2 (MAD) Cohort 3 | Experimental | MAD Dose 3 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 1 Part 2 (MAD) Cohort 4 | Experimental | MAD Dose 4 for Formulation A Receives: Drug: ASC36 Injection A, for subcutaneous use; Drug: ASC36 Placebo Injection A, for subcutaneous use |
| Section 2 Part 1 (SAD) Cohort 1 | Experimental | SAD Dose 1 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 1 (SAD) Cohort 2 | Experimental | SAD Dose 2 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 1 (SAD) Cohort 3 | Experimental | SAD Dose 3 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 1 (SAD) Cohort 4 | Experimental | SAD Dose 4 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 2 (MAD) Cohort 1 | Experimental | MAD Dose 1 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 2 (MAD) Cohort 2 | Experimental | MAD Dose 2 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 2 (MAD) Cohort 3 | Experimental | MAD Dose 3 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
| Section 2 Part 2 (MAD) Cohort 4 | Experimental | MAD Dose 4 for Formulation B Receives: Drug: ASC36 Injection B, for subcutaneous use; Drug: ASC36 Placebo Injection B, for subcutaneous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
A summary of AEs, SAEs, and other non-serious adverse events following single SC doses of ASC36 injection
Measured: 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
Measured: From baseline to the end of treatment (up to 20 weeks or Day 141)
Secondary outcomes (8)
Cmax of ASC36 Injection
Evaluate the peak plasma concentration of ASC36 Injection
Measured: 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
Measured: 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
Measured: 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%
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to the end of treatment (up to 20 weeks or Day 141)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start28 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Weight ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharma (China) Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893093
- Sponsor's protocol ID
- ASC36i-101
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No