Flank MassPhase 2NCT05445557
Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
A Phase 2 study testing RZL-012 in people with Flank Mass, run by Raziel Therapeutics Ltd. at 1 site in United States.
Trial summary
A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Flank Mass
- What is being tested?
- RZL-012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 10 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) BMI of ≥ 22 and < 30.
- Has clearly visible and palpable fat in the flanks
- Has symmetrical appearance of right and left flanks
- Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
- Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.
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- If female, is not pregnant or breastfeeding based on the following:
- agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 28 days after the last day of study drug and a negative urine pregnancy test at screening and baseline; or
- is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or
- is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause, having documented serum follicle-stimulating hormone (FSH) level > 40 mIU/mL, or having another documented medical condition (e.g., was born without a uterus))
- If male (with or without vasectomy), agree to the use of highly effective contraceptive methods, e.g. condom, from study baseline until 7 days after the last day of study drug.
- Is willing to avoid strenuous exercise for seven (7) days post treatment.
- Is motivated to adhere to the visit schedule and protocol requirements.
- Is willing and able to sign an Institutional Review Board (IRB) approved informed consent form (ICF) indicating that they are aware of the investigational nature of the study.
Who cannot join
- Is unable to tolerate subcutaneous injections.
- Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
- Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.
- Has medication or a history of coagulopathy.
- Has a history or family history of venous thrombotic disease.
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- Had a non-invasive fat reduction and/or body contouring procedure in the flanks within the past 12 months.
- Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.
- Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.
- Has an active dermatitis or open wound in the proposed treatment area.
- Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) > ULN, international normalized ratio (INR) > ULN reference range (> 1.3), prothrombin time (PT) > ULN.
- Has an active bacterial, fungal, or viral infection in the proposed treatment area.
- Has known allergic reactions to any injectables.
- Has been treated chronically in the past 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
- Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs).
- Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Phase Followed by An Open-Label Phase to Evaluate the Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After codes opening, a second treatment cycle on the previously untreated contralateral flank will be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.
Read the detailed description
This clinical trial is comprised of a double-blind, placebo-controlled phase followed by an open-label phase.
The double-blind, placebo-controlled phase of the trial will consist of a screening period, baseline visit and a 12-week post-treatment follow-up period. At the baseline visit, each flank (right and left) of each study participant will be randomized into either the active RZL-012 treatment group or the placebo group and each flank will receive multiple injections in a single session of RZL-012 or placebo. Blood samples will be collected for 6 of the 12 subjects for PK analyses. All subjects will be followed up for 12 weeks after the single treatment session.
Upon completion of the double-blind phase of the study, and the opening of codes subjects will be offered RZL-012 open-label treatment in the flank previously treated with placebo. Consenting subjects will be followed for safety and efficacy for an additional 12 weeks.
In both the double-blind and open-label phases of the study, subjects will be monitored for adverse events (AEs). Subjects will return to the site for visits at 1 week, 4 weeks, 8 weeks, and 12 weeks post treatment and will be monitored for safety and efficacy during these visits.
Subjects who will be collected with PK will return to the clinic at Day 1 post injection for further PK samples.
The dimensions of flanks will be measured using 3D images and volumetric calculations using Canfield 3D images.
- Conditions
- Flank Mass
- Being tested
- RZL-012, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZL-012Drug
small synthetic molecule for submental fat reduction
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RZL-012 50mg/ml | Active comparator | Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site. Receives: Drug: RZL-012 |
| Placebo | Placebo comparator | Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events [AEs]
Safety
Measured: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Secondary outcomes (5)
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
To compare the proportion of flanks having an improvement as indicated by reduction in score from 6 to 0 according to the Physician Global Assessment Scale (GAIS) in RZL-01-treated flanks vs placebo-treated flanks
Measured: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Efficacy - Change in Satisfaction Score
To compare the proportion of subjects who are satisfied with treatment results as indicated by a binary yes/no satisfaction questionnaire in RZL-012-treated flanks vs placebo-treated flanks
Measured: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Efficacy - Relative Change in Measured Fat Volume
Measure the relative mean reduction in volume (%) at post treatment vs. baseline for each of the treated flanks, as measured by 3D images using the Canfield 3D system in RZL-012-treated flanks vs placebo-treated flanks at 12 weeks vs. baseline
Measured: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatment
Efficacy -Number of Participant With Correct Identification by Reviewers
Blinded reviewers will identify, per patient, the flank treated with test compound (active) vs the flank treated with Placebo. Success will be defined as at least 70% correct identification vs the expected 50% correct identification based on random guessing
Measured: 12 weeks 12 weeks for the Double-Blind Phase
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Mar 2022
- Primary completion20 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Flank MassStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each of the subject's flanks will be randomized for RZL-012 and placebo injections.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raziel Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445557
- Sponsor's protocol ID
- RZL-012-FL-P2US-001
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Phase Followed by An Open-Label Phase to Evaluate the Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
- ClinicalTrials.gov ID
- NCT05445557
- Acronym / sponsor ID
- RZL-012-FL-P2US-001
- Conditions
- Flank Mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Raziel Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After codes opening, a second treatment cycle on the previously untreated contralateral flank will be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.
Detailed description
This clinical trial is comprised of a double-blind, placebo-controlled phase followed by an open-label phase.
The double-blind, placebo-controlled phase of the trial will consist of a screening period, baseline visit and a 12-week post-treatment follow-up period. At the baseline visit, each flank (right and left) of each study participant will be randomized into either the active RZL-012 treatment group or the placebo group and each flank will receive multiple injections in a single session of RZL-012 or placebo. Blood samples will be collected for 6 of the 12 subjects for PK analyses. All subjects will be followed up for 12 weeks after the single treatment session.
Upon completion of the double-blind phase of the study, and the opening of codes subjects will be offered RZL-012 open-label treatment in the flank previously treated with placebo. Consenting subjects will be followed for safety and efficacy for an additional 12 weeks.
In both the double-blind and open-label phases of the study, subjects will be monitored for adverse events (AEs). Subjects will return to the site for visits at 1 week, 4 weeks, 8 weeks, and 12 weeks post treatment and will be monitored for safety and efficacy during these visits.
Subjects who will be collected with PK will return to the clinic at Day 1 post injection for further PK samples.
The dimensions of flanks will be measured using 3D images and volumetric calculations using Canfield 3D images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each of the subject's flanks will be randomized for RZL-012 and placebo injections.
| Arm | Type | Receives |
|---|---|---|
| RZL-012 50mg/ml | Active comparator | Drug: RZL-012Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is a male or female subject between the ages of 18 and 65 years, inclusive.
- Has body mass index (BMI) BMI of ≥ 22 and < 30.
- Has clearly visible and palpable fat in the flanks
- Has symmetrical appearance of right and left flanks
- Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.
Key exclusion criteria (16 listed)
- Is unable to tolerate subcutaneous injections.
- Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).
- Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).
- Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.
- Has medication or a history of coagulopathy.
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 |
|---|---|---|
| RZL-012small synthetic molecule for submental fat reduction | Drug | RZL-012 50mg/ml |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-related Adverse Events [AEs]
Time frame: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Safety
5 secondary outcomes
Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale
Time frame: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Efficacy - Change in Satisfaction Score
Time frame: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase
Efficacy - Relative Change in Measured Fat Volume
Time frame: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatment
Efficacy -Number of Participant With Correct Identification by Reviewers
Time frame: 12 weeks 12 weeks for the Double-Blind Phase
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)
Time frame: 30 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RZL-012 in people with Flank Mass, run by Raziel Therapeutics Ltd. 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 14 inclusion and 16 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 Nov 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Treatment-related Adverse Events [AEs] (time frame: 12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2023.