Abdominal ObesityPhase 1NCT05422378
A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty
A Phase 1 study testing STP705 in people with Abdominal Obesity, run by Sirnaomics at 1 site in United States.
Trial summary
Dose-ranging, randomized, double-blind, vehicle-controlled study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 27 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To enter the study, a subject must meet the following criteria:
- Subject is a male or non-pregnant female 18-65 years of age.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 3/Baseline.
- Subject has agreed to undergo an abdominoplasty procedure, participate in this study, has minimally acceptable adipose tissue in the target areas per protocol, and meets all pre-operative requirements, in the opinion of the investigator and surgeon.
Who cannot join
- A subject is ineligible to enter the study if he/she meets one or more of the following criteria:
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a significant active systemic or localized abdominal infection.
- Subject has a body mass index (BMI) ≥40.
- Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
- Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as apixaban (Eliquis), etc. The use of such medications is precluded up to 7 days prior to Visit 3/Baseline and during the study period.
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- Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., HIV positive, malignancy), medication use, or other factors.
- Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism or excretion.
- Subject has local skin condition(s) (e.g., rash, scarring, and tattoos) or inadequate injection sites in the region designated for abdominoplasty excision which are inappropriate for participation in the study, in the opinion of the investigator.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to first injection of the test article.
- Subject has a history of sensitivity to any of the ingredients in the test articles (see Section 6.1).
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty
Dose-ranging, randomized, double-blind, vehicle-controlled study
Read the detailed description
Subject will receive a single injection for each treatment which all 3 test article concentrations and both injection volumes and the vehicle for a total of 7 treatments.
Subjects will receive test articles in 3 visits.
- Conditions
- Abdominal Obesity
- Being tested
- STP705
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP705Drug
Also called STP705 Powder for Injection
STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
| Study group | Role | What they receive |
|---|---|---|
| STP705, 120ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc Receives: Drug: STP705 |
| STP705, 120ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc Receives: Drug: STP705 |
| STP705, 240 ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc Receives: Drug: STP705 |
| STP705, 240ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc Receives: Drug: STP705 |
| STP705, 320ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc Receives: Drug: STP705 |
| STP705, 320ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc Receives: Drug: STP705 |
| Vehicle | Placebo comparator | 1.0cc placebo Receives: Drug: STP705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
LSR scale will be used by investigator to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, limited involvement, 2= moderate involvement, and 3= severe, extreme involvement)
Measured: 24 weeks
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.
LSR scale will be used by subjects to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, 2= moderate, and 3= severe)
Measured: 24 weeks
Incidence (severity and causality) of any AEs
AE's will be classified using CTCAE v.5.0
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Aug 2022
- Primary completion3 Feb 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose-ranging, double-blind, vehicle-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Nestor, MD, Principal investigator, Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422378
- Sponsor's protocol ID
- SRN-705-010
- Status last verified
- Mar 2024
- First submitted
- 8 Jun 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nestor MS, Hetzel J, Awad N, Bhupalam V, Lu P, Molyneaux M. A Novel Injectable Polypeptide Nanoparticle Encapsulated siRNA Targeting TGF-beta1 and COX-2 for Localized Fat Reduction II: Phase I Clinical Trial. J Cosmet Dermatol. 2025 Feb;24(2):e16722. doi: 10.1111/jocd.16722. Epub 2024 Dec 18.
PubMed 39692702
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT05422378
- Acronym / sponsor ID
- SRN-705-010
- Conditions
- Abdominal Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dose-ranging, randomized, double-blind, vehicle-controlled study
Detailed description
Subject will receive a single injection for each treatment which all 3 test article concentrations and both injection volumes and the vehicle for a total of 7 treatments.
Subjects will receive test articles in 3 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Dose-ranging, double-blind, vehicle-controlled
| Arm | Type | Receives |
|---|---|---|
| STP705, 120ug/mL, 0.5 cc | Experimental | Drug: STP705Volume of Injection 0.5cc |
| STP705, 120ug/mL, 1.0 cc | Experimental | Drug: STP705Volume of Injection 1.0cc |
| STP705, 240 ug/mL, 0.5 cc | Experimental | Drug: STP705Volume of Injection 0.5cc |
| STP705, 240ug/mL, 1.0 cc | Experimental | Drug: STP705Volume of Injection 1.0cc |
| STP705, 320ug/mL, 0.5 cc | Experimental | Drug: STP705Volume of Injection 0.5cc |
| STP705, 320ug/mL, 1.0 cc | Experimental | Drug: STP705Volume of Injection 1.0cc |
| Vehicle | Placebo comparator | Drug: STP7051.0cc placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a male or non-pregnant female 18-65 years of age.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 3/Baseline.
- Subject has agreed to undergo an abdominoplasty procedure, participate in this study, has minimally acceptable adipose tissue in the target areas per protocol, and meets all pre-operative requirements, in the opinion of the investigator and surgeon.
Key exclusion criteria (13 listed)
- A subject is ineligible to enter the study if he/she meets one or more of the following criteria:
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a significant active systemic or localized abdominal infection.
- Subject has a body mass index (BMI) ≥40.
- Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP705Also: STP705 Powder for InjectionSTP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually. | Drug | STP705, 120ug/mL, 0.5 cc, STP705, 120ug/mL, 1.0 cc, STP705, 240 ug/mL, 0.5 cc, STP705, 240ug/mL, 1.0 cc, STP705, 320ug/mL, 0.5 cc, STP705, 320ug/mL, 1.0 cc, Vehicle |
Primary outcome
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
Time frame: 24 weeks
LSR scale will be used by investigator to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, limited involvement, 2= moderate involvement, and 3= severe, extreme involvement)
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.
Time frame: 24 weeks
LSR scale will be used by subjects to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, 2= moderate, and 3= severe)
Incidence (severity and causality) of any AEs
Time frame: 24 weeks
AE's will be classified using CTCAE v.5.0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 39692702Nestor MS, Hetzel J, Awad N, Bhupalam V, Lu P, Molyneaux M. A Novel Injectable Polypeptide Nanoparticle Encapsulated siRNA Targeting TGF-beta1 and COX-2 for Localized Fat Reduction II: Phase I Clinical Trial. J Cosmet Dermatol. 2025 Feb;24(2):e16722. doi: 10.1111/jocd.16722. Epub 2024 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Nestor, MD principal investigator
Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STP705 in people with Abdominal Obesity, run by Sirnaomics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising. (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05422378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.