Chronic Weight Management study: ASC36 Injection A vs ASC36 Injection B
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Formulations of ASC36 Injection in Participants With Obesity or Overweight
ClinicalTrials.gov ID: NCT07893093
What this study is testing
What is ASC36 Injection A, for subcutaneous use?
ASC36 Injection A, for subcutaneous use is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic weight management.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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).
- Is a woman of nonchildbearing potential (postmenopausal [12 months of amenorrhea with follicle-stimulating hormone level consistent with a...
- 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...
You likely can't join if
- 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...
- 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...
- Have a lifetime history of suicide attempt.
See the full eligibility criteria
- 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).
- 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)]
- 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.
- 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...
- 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.
- 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.
- 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: i. systolic blood pressure (SBP) ≥160 mmHg ii. diastolic blood pressure (DBP) ≥100 mmHg
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.