Chronic Weight ManagementPhase 1NCT07893106
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Overweight
A Phase 1 study testing ASC36 tablets, for oral use in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
Trial summary
This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight 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 tablets, for oral use
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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) at screening.
- 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≥30 mIU/mL)]; or surgically sterile [hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation]).
- Is a WOCBP and agrees to use a highly effective contraceptive method (heterosexual abstinence as a lifestyle, or a male condom in conjunction with a second method of contraception that is one of the following: established combined estrogen and/or progesterone hormonal contraception (e.g. oral contraceptive pill), depot injection, contraceptive implant, or intra-uterine device) and refrain from donating egg starting from one month before the first dose and lasting until 6 months or 5 half lives, whichever is longer, after the last dose.
Who cannot join
- Have evidence of any clinically significant active or chronic disease (with the exception of obesity or overweight).
- 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 drugs that promote weight loss within 6 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.
- Have a lifetime history of suicide attempt.
Show all 21Show fewer
- 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 > 1.5x ULN;
- ALT > 1.5x 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 (> 200 ms)
- Intermittent second or third-degree AV block, or AV dissociation
- Right bundle branch block (RBBB), left bundle branch block (LBBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) (defined as QRS duration >120 ms).
- Elevated resting pulse rate (>100 bpm)
- Have poorly controlled high blood pressure per Investigator's judgment during screening
- Have abnormal values in calcitonin, magnesium, parathyroid hormone (PTH), vitamin D (25-hydroxycholecalciferol), and calcitriol per Investigator discretion.
- Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease) per Investigator discretion
- Has had prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascletis Clinical Site
South Miami, Florida, 33143
Ascletis Recruiting
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 ASC36 Tablets for Oral Use in Adult Participants With Obesity or Are Overweight
This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight
- Conditions
- Chronic Weight Management
- Being tested
- ASC36 tablets, for oral use, ASC36 placebo tablets
- 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 tablets, for oral useDrug
ASC36 tablets are an investigational formulation of ASC36 administered orally
ASC36 placebo tabletsDrug
ASC36 placebo tablets are a plaecbo formulation matching ASC36 tablets, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SAD) Cohort 1 | Experimental | SAD Dose 1 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 1 (SAD) Cohort 2 | Experimental | SAD Dose 2 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 1 (SAD) Cohort 3 | Experimental | SAD Dose 3 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 1 (SAD) Cohort 4 | Experimental | SAD Dose 4 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 1 (SAD) Cohort 5 | Experimental | SAD Dose 5 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 2 (MAD) Cohort 1 | Experimental | MAD Dose 1 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 2 (MAD) Cohort 2 | Experimental | MAD Dose 2 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
| Part 2 (MAD) Cohort 3 | Experimental | MAD Dose 3 Receives: Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets |
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 oral dose of ASC36 tablets
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Secondary outcomes (10)
Cmax of ASC36 Tablets
Evaluate the peak plasma concentration of ASC36 tablets
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Tmax of ASC36 Tablets
Evaluate the time to reach peak plasma concentration of ASC36 tablets
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
AUC of ASC36 Tablets
Evaluate the area under the plasma concentration-time curve of ASC36 tablets
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Half-life of ASC36 Tablets
Evaluate the time required for the plasma concentration of ASC36 to decrease by 50%
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in Body Weight
Percent Change From Baseline in Body Weight
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in Body Weight
Absolute Change From Baseline in Body Weight
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in Waist Circumference
Percent Change From Baseline in Waist Circumference
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in Waist Circumference
Absolute Change From Baseline in Waist Circumference
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in BMI
Percent Change From Baseline in BMI
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in BMI
Absolute Change From Baseline in BMI
Measured: From baseline to the end of treatment (up to 10 weeks or Day 70)
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 start13 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 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
- 86 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
- NCT07893106
- Sponsor's protocol ID
- ASC36o-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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ASC36 Tablets for Oral Use in Adult Participants With Obesity or Are Overweight
- ClinicalTrials.gov ID
- NCT07893106
- Acronym / sponsor ID
- ASC36o-101
- Conditions
- Chronic Weight Management
- Keywords
- Chronic Weight Management, Obesity, Amylin receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SAD) Cohort 1 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsSAD Dose 1 |
| Part 1 (SAD) Cohort 2 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsSAD Dose 2 |
| Part 1 (SAD) Cohort 3 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsSAD Dose 3 |
| Part 1 (SAD) Cohort 4 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsSAD Dose 4 |
| Part 1 (SAD) Cohort 5 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsSAD Dose 5 |
| Part 2 (MAD) Cohort 1 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsMAD Dose 1 |
| Part 2 (MAD) Cohort 2 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsMAD Dose 2 |
| Part 2 (MAD) Cohort 3 | Experimental | Drug: ASC36 tablets, for oral use, Drug: ASC36 placebo tabletsMAD Dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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) at screening.
- 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:
Key exclusion criteria (21 listed)
- Have evidence of any clinically significant active or chronic disease (with the exception of obesity or overweight).
- 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 drugs that promote weight loss within 6 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC36 tablets, for oral useASC36 tablets are an investigational formulation of ASC36 administered orally | Drug | Part 1 (SAD) Cohort 1, Part 1 (SAD) Cohort 2, Part 1 (SAD) Cohort 3, Part 1 (SAD) Cohort 4, Part 1 (SAD) Cohort 5, Part 2 (MAD) Cohort 1, Part 2 (MAD) Cohort 2, Part 2 (MAD) Cohort 3 |
| ASC36 placebo tabletsASC36 placebo tablets are a plaecbo formulation matching ASC36 tablets, administered orally | Drug | Part 1 (SAD) Cohort 1, Part 1 (SAD) Cohort 2, Part 1 (SAD) Cohort 3, Part 1 (SAD) Cohort 4, Part 1 (SAD) Cohort 5, Part 2 (MAD) Cohort 1, Part 2 (MAD) Cohort 2, Part 2 (MAD) Cohort 3 |
Primary outcome
Adverse Events
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
A summary of AEs, SAEs, and other non-serious adverse events following single oral dose of ASC36 tablets
10 secondary outcomes
Cmax of ASC36 Tablets
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Tmax of ASC36 Tablets
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
AUC of ASC36 Tablets
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Half-life of ASC36 Tablets
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in Body Weight
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in Body Weight
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in Waist Circumference
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in Waist Circumference
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Percent Change From Baseline in BMI
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Absolute Change From Baseline in BMI
Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASC36 tablets, for oral use in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ascletis Recruiting (+1 2068073688, clinicaltrials@ascletis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.