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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
STP705
DrugThe investigational product (IP) in this study, STP705, targets 2 key proteins that play a key role in inflammation and remodelling of adipose tissue: transforming growth factor beta 1 (TGF-β1) and cyclooxygenase 2 (COX-2). TGF-β1 influences the release of inflammation mediators and promotes remodelling and collagen deposition in adipose tissue. In addition, the COX-2 gene has been shown to be highly expressed and elevated in adipose tissue under morbid obesity conditions, and COX-2 activation is a key factor contributing to the inflammation associated with obesity.
Treatment groups
Trial outcomes
Primary outcomes
The efficacy of STP705 injection for SMF reduction
Percentage of participants with a ≥ 1-grade improvement in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score from Baseline to the End-of-Study Visit (Day 85). Percentage of participants with a ≥ 1-grade improvement in Participant-Reported Submental Fat Rating Scale (PR-SMFRS) score from Baseline to the End-of-Study Visit (Day 85).
Secondary outcomes
The efficacy of STP705 injection for SMF reduction
Change From Baseline in CR-SMFRS score at each timepoint. Percentage of participants with a ≥ 2-grade improvement in CR-SMFRS score at each timepoint.
The participant satisfaction on STP705 injection for SMF reduction
Change From Baseline in Participant-Self Satisfaction Scale (PSSS) sore at each timepoint.
The safety and tolerability of STP705 injections for SMF reduction
Incidence and severity of TEAEs. Incidence and severity of injection site reactions (ISRs). Incidence and severity of local skin reactions (LSRs). Incidence and severity of participant-reported assessments (pain, stinging, and burning).
The participant satisfaction on STP705 injection for SMF reduction
Change From Baseline in Participant -Reported Submental Fat Impact Scale (PR-SMFIS) at each timepoint.
Sponsors and contacts
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Sirnaomics
Lead sponsor
Emeritus Research
Collaborator