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RecruitingNCT07893106Updated Oct 23, 2026

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 interventional study of ASC36 tablets, for oral use and ASC36 placebo tablets 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. 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

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Weight Management

Browse trials for

Keywords

  • Chronic Weight Management
  • Obesity
  • Amylin receptor
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 86 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

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.

Browse Ascletis Pharma (China) Co., Limited studies →All Ascletis Pharma Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Have provided informed consent before initiation of any study-specific procedures.
  2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive) at screening.
  3. Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to \<30 kg/m2).

  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. Have evidence of any clinically significant active or chronic disease (with the exception of obesity or overweight).
  2. 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.
  3. Have used prescription drugs that promote weight loss within 6 months prior to the first dose of investigational product.
  4. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
  5. Presence/history of cardiovascular disease incl. stable/unstable angina, MI, TIA, stroke, cardiac decompensation, clinically significant arrhythmias or conduction disorders.
  6. Have a lifetime history of suicide attempt.
  7. Participants who have any history of hypersensitivity or intolerance to amylin receptor agonists, related compounds, or drugs of similar mechanisms of action (MoA).

  8. 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.

  9. 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)
  10. Have poorly controlled high blood pressure per Investigator's judgment during screening
  11. Have abnormal values in calcitonin, magnesium, parathyroid hormone (PTH), vitamin D (25-hydroxycholecalciferol), and calcitriol per Investigator discretion.
  12. 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
  13. Has had prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab)
05

Study design

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

Study arms

  • Experimental
    Part 1 (SAD) Cohort 1

    SAD Dose 1

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 1 (SAD) Cohort 2

    SAD Dose 2

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 1 (SAD) Cohort 3

    SAD Dose 3

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 1 (SAD) Cohort 4

    SAD Dose 4

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 1 (SAD) Cohort 5

    SAD Dose 5

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 2 (MAD) Cohort 1

    MAD Dose 1

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 2 (MAD) Cohort 2

    MAD Dose 2

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

  • Experimental
    Part 2 (MAD) Cohort 3

    MAD Dose 3

    Drug: ASC36 tablets, for oral use · Drug: ASC36 placebo tablets

Interventions

  • DrugASC36 tablets, for oral use

    ASC36 tablets are an investigational formulation of ASC36 administered orally

  • DrugASC36 placebo tablets

    ASC36 placebo tablets are a plaecbo formulation matching ASC36 tablets, administered orally

06

What researchers measure

Primary outcomes

  1. Adverse Events

    A summary of AEs, SAEs, and other non-serious adverse events following single oral dose of ASC36 tablets

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

Secondary outcomes

  1. Cmax of ASC36 Tablets

    Evaluate the peak plasma concentration of ASC36 tablets

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  2. Tmax of ASC36 Tablets

    Evaluate the time to reach peak plasma concentration of ASC36 tablets

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  3. AUC of ASC36 Tablets

    Evaluate the area under the plasma concentration-time curve of ASC36 tablets

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  4. Half-life of ASC36 Tablets

    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 10 weeks or Day 70)

  5. 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 10 weeks or Day 70)

  6. Absolute Change From Baseline in Body Weight

    Absolute Change From Baseline in Body Weight

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  7. 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 10 weeks or Day 70)

  8. Absolute Change From Baseline in Waist Circumference

    Absolute Change From Baseline in Waist Circumference

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  9. Percent Change From Baseline in BMI

    Percent Change From Baseline in BMI

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

  10. Absolute Change From Baseline in BMI

    Absolute Change From Baseline in BMI

    Time frame: From baseline to the end of treatment (up to 10 weeks or Day 70)

07

Study locations

1 of 1 sites recruiting
  • Ascletis Clinical Site
    South Miami, Florida 33143, United States
    • Ascletis Recruiting · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.

Of 257 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 6 months is below that.

Counting every sponsor, half of 328 studies reached it within 11 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 23, 2026
StartActual
Oct 13, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07893106
Lead sponsor
Ascletis Pharma (China) Co., Limited
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Oct 13, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 23, 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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