Two ASC36 injections in adults with obesity or overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 trial is randomized, double-blind, and compares two ASC36 injection formulations with placebos in adults aged 18–65 who have obesity or are overweight. It uses single and multiple ascending doses to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. The study uses subcutaneous injections and includes healthy-appearing participants with BMI criteria to assess initial dosing and response. Primary goals are safety and how the body's exposure to the drug changes with dose, guiding further development.

Why it matters

Who can join: the full rules

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).

Where it's running

• Ascletis Clinical Site
  San Antonio, Texas, United States Recruiting
• Ascletis Clinical Site
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Ascletis Recruiting
• Email: clinicaltrials@ascletis.com
• Phone: +1 2068073688

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ASC36 tablets in adults with obesity or overweight

  A small study will test ASC36 tablets to see if they are safe and tolerated in adults with obesity or overweight, compared to placebo.

  Recruiting Phase 1 Ascletis Pharma Inc · South Miami, Florida · NCT07893106

• ASC35 Injection in People with Overweight or Obesity

  This study tests ASC35 injections to see if they are safe and well tolerated in adults with overweight or obesity.

  Recruiting Phase 1 Ascletis Pharma Inc · Baltimore, Maryland · NCT07842640

• Once-daily ASC30 for adults who are overweight or obese with weight-related health issues

  This study tests whether three different daily doses of ASC30 can help adults who are overweight or obese with related health problems lose weight and stay safe.

  Recruiting at 6 sites Phase 3 Ascletis Pharma Inc · Birmingham, Alabama and 121 other locations · NCT07743463

• Once-daily ASC30 to See if it helps adults with obesity or overweight and Type 2 diabetes

  This study tests three daily doses of ASC30 against placebo in adults who are overweight or obese and have Type 2 diabetes to see if it helps with weight loss and safety over time.

  Recruiting at 6 sites Phase 3 Ascletis Pharma Inc · Birmingham, Alabama and 134 other locations · NCT07743450

• Aleniglipron for adults with overweight/obesity and type 2 diabetes

  A long-term test to see if aleniglipron helps weight loss and blood sugar control in adults who are overweight or obese and have type 2 diabetes.

  Recruiting at 57 sites Phase 3 Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Birmingham, Alabama and 73 other locations · NCT07654374

• Aleniglipron for weight management in obesity or overweight with a related condition

  This study tests whether aleniglipron, taken daily, helps people with obesity or overweight plus a weight-related condition lose weight when added to a reduced-calorie diet and more activity, compared with a placebo.

  Recruiting at 13 sites Phase 3 Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Birmingham, Alabama and 70 other locations · NCT07654361

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.