Trial reportLipids in health and disease2024
Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat.
Trial report in Lipids in health and disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05476094 (A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose Phase Ⅰ Study to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. Injection in Healthy Subjects), which is not on this map. Not yet cited in PubMed.
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A Randomized, Double-blind, Placebo-controlled, Single Center and Single Dose Phase Ⅰ Study to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of AYP-101 S.C. Injection in Healthy Subjects
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5 authors.
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Abstract
backgroundExcessive submental fat under the chin is a known aesthetic concern because of its negative impact on facial appearance and psychological well-being. AYP-101 is a newly developed injectable agent containing 93% soybean phosphatidylcholine (SPC) designed to reduce submental fat. We conducted a phase 1 study to evaluate the safety, pharmacokinetic (PK), and lipid profile effects of AYP-101.
methodsThis study was a randomized, double-blind, placebo-controlled, single-dose, two-cohort trial. Participants were randomized into groups receiving 250 mg of AYP-101, 500 mg of AYP-101, or placebo at a 9:9:8 ratio across both cohorts. Safety was assessed through standard clinical evaluations. Blood samples were collected up to 144 h postdose in cohort 1 and up to 48 h postdose in cohort 2. The PK parameters were calculated via noncompartmental analysis.
resultsAll 26 randomized subjects completed the study. A total of 72 solicited adverse drug reactions (ADRs) were reported by 24 subjects, all of which were mild. The most common ADRs were injection site pain and bruising. There were 29 ADR cases in the 250 mg group; 26 cases in the 500 mg group; and 18 cases in the placebo group, indicating that there were no clinically significant differences in the safety profiles between the groups. All the dose groups presented similar PK profiles, with C
conclusionsAYP-101 appears to be a safe candidate for treating submental fat, with localized reactions and no systemic exposure at single subcutaneous doses of up to 500 mg.
trial registrationClinicalTrials.gov NCT05476094.
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