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STP705 Injection for Submental Fat Reduction

NCT07677683 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Submental Fullness

Interventions

DRUG

STP705

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.

Sponsors & Collaborators

  • Emeritus Research

    collaborator NETWORK

  • Sirnaomics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-28
Primary Completion
2027-07-25
Completion
2027-09-25
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677683 on ClinicalTrials.gov