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| Name | Class |
|---|---|
| Emeritus Research | NETWORK |
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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:
Participant Study Duration: Total duration of study participation for each participant: Approximately 16 weeks (4 weeks Screening, 8 weeks Treatment, and 4 weeks Follow-up).
Number of Participants (Planned): Approximately 30 participants will be enrolled into the study.
Diagnosis and Main Criteria for Inclusion:
To be eligible for this study, a participant must meet all of the following inclusion criteria:
A participant who meets any of the following exclusion criteria must be excluded from the study:
Treatment Duration:
Each participant will be administered 7 SC injections of the IP in the submental region during each treatment. Treatment with STP705 will be given on Day 1, Day 29, and Day 57.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Cohort 1: 40 µg STP705 per injection. Up to 280 µg in total (n = 10 participants) |
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| Cohort 2 | Active Comparator | Cohort 2: 64 µg STP705 per injection. Up to 448 µg in total (n = 10 participants) |
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| Cohort 3 | Active Comparator | Cohort 3: 80 µg STP705 per injection. Up to 560 µg in total (n = 10 participants) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STP705 | Drug | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline to day85 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening Visit, Day 1, Day 29, Day 57, Day 85 |
| The participant satisfaction on STP705 injection for SMF reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li VP of Medical Affairs and Clinical Operation, Medical Doctor | Contact | 86 18012145716 | kevinli@sirnaomics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emeritus Research Sydney | Sydney | New South Wales | 2019 | Australia |
Individual participant data (IPD) will not be made available for sharing. This decision was made to protect the confidentiality of study participants in accordance with the study protocol and applicable privacy regulations.
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Change From Baseline in Participant-Self Satisfaction Scale (PSSS) sore at each timepoint. |
| Screening Visit, Day 1, Day 29, Day 57, Day 85 |
| 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). | Screening Visit, Day 1, Day 29, Day 57, Day 85 |
| The participant satisfaction on STP705 injection for SMF reduction | Change From Baseline in Participant -Reported Submental Fat Impact Scale (PR-SMFIS) at each timepoint. | Screening Visit, Day 1, Day 29, Day 57, Day 85 |
| The efficacy of STP705 injection for SMF reduction | Change From Baseline in PR-SMFRS at each timepoint. Percentage of participants with a ≥ 2-grade improvement in PR-SMFRS score at each timepoint. | Screening Visit, Day 1, Day 29, Day 57, Day 85 |