A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection in Participants With Obesity or Overweight
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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"
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of two forms of ASC36 injection in otherwise healthy adults with obesity or overweight. It also looks at how the body handles the drug and how the drug affects the body. Participants receive ASC36 or a placebo, an injection with no study drug.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Agree to join the study before any study tests or procedures.
- Be 18 to 65 years old and a nonsmoker.
- Be otherwise healthy and have a BMI of 27 or higher. BMI is a measure of weight compared with height.
- Women must not be pregnant, breastfeeding, or planning to breastfeed.
- Women must either be unable to become pregnant or use highly effective birth control.
- Women who can become pregnant must use birth control from 1 month before the first dose until at least 6 months after the last dose. A longer time may be needed based on how long the drug stays in the body.
- Women using hormonal birth control should also use a male condom with spermicide, which kills sperm. The study drug may make hormonal birth control less effective.
Who can't join
- Have a serious current or long-term disease, or obesity caused by a medical, hormone, or genetic condition.
- Used prescription or experimental weight-loss drugs within 3 months before the first study dose.
- Have ever had type 1 or type 2 diabetes, or certain severe blood sugar emergencies.
- Have heart or blood vessel disease, certain abnormal heart tracing results, a resting pulse over 100, or poorly controlled blood pressure of 160 or higher on top or 100 or higher on bottom.
- Have ever attempted suicide.
- Have had an allergic reaction to, or could not tolerate, amylin receptor agonists or similar drugs. These drugs act on certain hormone signals in the body.
- Have liver disease, signs of liver disease, hepatitis (liver swelling), or liver blood test results above the study's limits.
- Have certain abnormal hormone, vitamin D, calcium, or magnesium test results; a condition affecting calcium or bone renewal; or past treatment with bisphosphonates or denosumab for weak bones.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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). 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 \[FSH≥40 mIU/mL)\]; 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 Exclusion Criteria: 1. Have evidence of any clinically significant active or chronic disease. 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 or investigational drugs that promote weight loss within 3 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, per PI discretion. 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 \> 2x ULN; * ALT \> 2x 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 (\> 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) 10. 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 11. 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. 12. Have a presence or history of any disorder affecting calcium metabolism and bone turnover (such as hyperparathyroidism, hypoparathyroidism or Paget´s disease) 13. Prior treatment with antiresorptive agents for osteoporosis (bisphosphonates or denosumab).
Study sites (2)
TX
- Ascletis Clinical Site · San Antonio, TX 78232Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in San Antonio
UT
- Ascletis Clinical Site · Salt Lake City, UT 84124Ascletis Recruiting · Study contact · clinicaltrials@ascletis.comMore trials in Salt Lake City