Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-24 @ 6:46 PM
NCT ID:
NCT05445557
Eligibility Criteria:
Inclusion Criteria:
* Is a male or female subject between the ages of 18 and 65 years, inclusive.
* Has body mass index (BMI) BMI of ≥ 22 and \< 30.
* Has clearly visible and palpable fat in the flanks
* Has symmetrical appearance of right and left flanks
* Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
* Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.
* If female, is not pregnant or breastfeeding based on the following:
1. agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 28 days after the last day of study drug and a negative urine pregnancy test at screening and baseline; or
2. is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or
3. is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause, having documented serum follicle-stimulating hormone (FSH) level \> 40 mIU/mL, or having another documented medical condition (e.g., was born without a uterus))
* If male (with or without vasectomy), agree to the use of highly effective contraceptive methods, e.g. condom, from study baseline until 7 days after the last day of study drug.
* Is willing to avoid strenuous exercise for seven (7) days post treatment.
* Is motivated to adhere to the visit schedule and protocol requirements.
* Is willing and able to sign an Institutional Review Board (IRB) approved informed consent form (ICF) indicating that they are aware of the investigational nature of the study.
Exclusion Criteria:
* Is unable to tolerate subcutaneous injections.
* Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
* Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
* Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.
* Has medication or a history of coagulopathy.
* Has a history or family history of venous thrombotic disease.
* Had a non-invasive fat reduction and/or body contouring procedure in the flanks within the past 12 months.
* Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.
* Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
* Has an active dermatitis or open wound in the proposed treatment area.
* Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) \> ULN, international normalized ratio (INR) \> ULN reference range (\> 1.3), prothrombin time (PT) \> ULN.
* Has an active bacterial, fungal, or viral infection in the proposed treatment area.
* Has known allergic reactions to any injectables.
* Has been treated chronically in the past 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
* Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs).
* Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05445557
Study Brief:
Protocol Section:
NCT05445557