STP705 Injection for Submental Fat Reduction

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSirnaomics

About this trial

This Phase 2 study aims to assess the efficacy of SC injections of STP705 for the reduction of Submental fat in apopulation of healthy adult volunteers, and to further establish its safety and tolerability.

The primary objective is to evaluate the efficacy of STP705 injection for Submental fat reduction. The second objective is to evaluate the safety and tolerability of STP705 injection.

This is an open-label study. Eligible participants will be sequentially enrolled into 1 of 3 treatment cohorts, as follows:

Cohort 1: 40 µg STP705 per injection. Up to 280 µg in total (n = 10 participants) Cohort 2: 64 µg STP705 per injection. Up to 448 µg in total (n = 10 participants) Cohort 3: 80 µg STP705 per injection. Up to 560 µg in total (n = 10 participants)

The STP705 powder will be reconstituted with dextrose 5% in water (D5W). A total of 7 injections (3.5 mL total volume) in a single treatment may be administered to each participant in the submental triangle area (ie, for a total dose of up to 280 µg, 448 µg or 560 µg STP705 for each cohort). The Submental fat injections will be performed at Day 1/Baseline, Day 29, and Day 57 , pending favourable reviews by the Investigator of injection site reactions (ISRs), local skin reactions (LSRs), and participant assessments of the injection sites (pain, stinging, and burning). To proceed with treatment at Day 29 or Day 57, the following factors will be considered:

1. the total tolerability score per injection site (defined as the sum of the "Investigator assessed LSRscores" and the "participant-reported scores of injection site pain and stinging/burning" measured prior totreatment must be \< 6, and 2. there are no findings (eg, systemic and/or local adverse events \[AEs\]) that would preclude treatment, in the opinion of the Investigator. The tolerability score threshold should be interpreted in conjunction with clinical judgment. If condition a) is not met, participants with a total tolerability score = 6 will not be injected with the study medications. After the 3rd injection, the participant will be followed for 1 month (through to Day 85). To proceed with dose escalation (ie, from Cohort 1 to Cohort 2 or from Cohort 2 to Cohort 3), the last participant in the previous dose cohort must have completed at least 7 days of postdose safety follow-up after the first injection, and available safety data will be reviewed by the Sponsor and Medical Monitor. The decision to escalate dose will be made upon review of all data by the Medical Monitor and the Sponsor and recommendation by the Sponsor.

Eligibility criteria

Qualifiers

Aged 18 to 65 years of age, inclusive, at the time of Screening.

Body mass index of ≤ 40.0 kg/m2.

Good general health, in the opinion of the Investigator or designee, with no clinically significant medical history, and have no clinically significant abnormalities on physical examination, electrocardiogram (ECGs), or laboratory assessments at Screening and/or before the first administration of the IP.

Grade 2 or 3 Submental fat, as assessed by the Investigator using the Clinician-Reported-Submental Fat Rating Scale (CR-SMFRS) AND as assessed by the participant using the Participant-Reported- Submental Fat Rating Scale (PR-SMFRS).

Disqualifiers

History of any intervention to treat Submental fat (eg, liposuction, surgery, or lipolytic agents).

Treatment with botulinum toxin injections in the neck or chin area within 6 months prior to the first dosing with the IP through the end of study (EOS).

History of trauma associated with the chin or neck areas that in the judgement of the Investigator may affect evaluation of safety or efficacy of treatment.

Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localised Submental fat.

Trial design

Treatments tested in this trial

  • STP705

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sirnaomics

Lead sponsor

Emeritus Research

Collaborator