Assess Impact of Poly-L-lactic Acid on GLP1 Subjects
Prospective, Single Center, Open-label Study Assessing Impact of Poly-L-lactic Acid on Adipogenesis in Patients on Glucagon-like Peptide-1 Agonists
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
-
Estimated enrollment
20
Study population
-
Eligibility highlights
•Female
Primary endpoint
•Physical Global Aesthetic Improvement Scale
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who can enroll
Inclusion criteria
1. Adult women aged 25-65 years.
2. Fitzpatrick skin types I-IV.
3. Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators.
4. Stable weight for 3 months, with body mass index (BMI) of 27 or less.
5. Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months, for 15 of the enrolled subjects. Remaining 5 subjects should not be taking or have a history of taking a GLP-1 agonist medication, and should not be planning to take a GLP-1 in the foreseeable future.
6. Must be willing to sign a photography release and ICF, and complete the entire course of the study.
7. Subjects in good general health based on investigator's judgment and medical history.
8. Negative urine pregnancy test result at the time of study entry (if applicable).
9. Subjects of childbearing potential must agree to use an effective method of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
1. Acceptable forms of birth control are: oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device/coil, double-barrier methods (e.g., sponge, spermicide, or condoms). Abstinence and/or vasectomized partner must agree to a second acceptable method of birth control (double-barrier) should the subject become sexually active.
2. A female is considered of non-childbearing potential if she is: postmenopausal (no menses for at least 12 months), without a uterus (hysterectomy) and/or both ovaries (oophorectomy), or bilateral tubal ligation.
Exclusion criteria
1. The presence of severe abdominal skin laxity as determined by clinical investigators.
2. Still actively losing weight.
3. Pregnancy or planned pregnancy during the study or currently breastfeeding.
4. Any uncontrolled systemic disease.
5. History of autoimmune connective tissue disease.
6. Current use of immunosuppressive medication.
7. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
8. Active dermatitis or active infection in the proposed treatment area.
9. Mesotherapy; dermal fillers, biostimulator injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery during the 12-month period before study treatment.
10. Any investigational treatment for skin quality of the abdomen during the 12-month period before the study treatment
11. Creams/cosmeceuticals and/or home therapies for the prevention or treatment of skin quality in the treatment area during the 1-month period before study treatment
12. Subjects with scarring in the treatment areas, including laparoscopic or abdominal surgery scars, which in the opinion of the investigator could impact results. Subjects with a history of keloids will be excluded.
13. Subjects who spray tanned or used sunless tanners in the treatment areas 1-month prior to study treatment.
14. History of bleeding disorder, concomitant use of anticoagulants, history of connective tissue disease (e.g., lupus, scleroderma), history of Bell's Palsy, epilepsy, smoking, and/or current pregnancy or breastfeeding .
15. Inability to ambulate following the procedure.
16. History of lidocaine and/or epinephrine sensitivity deemed by the investigator to preclude subject from enrolling into study.
17. Individuals with known allergies or sensitivities to any of the ingredients of any topical or injectable products being used in this study.
18. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other (unclassified)
2 endpointsPhysical Global Aesthetic Improvement Scale
Time frame:Month 3 and Month 9
descriptive
Subject Global Aesthetic Improvement Scale
Time frame:Month 3 and Month 9
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.