RZL-012 for Double Chin

Overseen By Racheli Gueta, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Raziel Therapeutics Ltd.

Must not be taking: Steroids, NSAIDs, Anticoagulants, others

Disqualifiers: Systemic disease, Skin laxity, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a second session with RZL-012, an injectable treatment, can further reduce submental fullness (fat under the chin) in individuals who have previously used it. It targets those who completed earlier trials with RZL-012 and still exhibit noticeable chin fullness. Participants must maintain a stable weight and have no major health issues or conditions that could interfere with the treatment. During the trial, RZL-012 will be injected under the chin, and participants will be monitored for safety and effectiveness for at least 84 days. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as non-steroidal anti-inflammatory drugs (NSAIDs) and anticoagulation therapies, at least one week before the study. If you are on systemic steroids or immunosuppressive drugs, you must have stopped them at least three months before joining the study.

Is there any evidence suggesting that RZL-012 is likely to be safe for humans?

Studies have shown that RZL-012 can safely and effectively reduce fat under the chin. In earlier research, patients received RZL-012 in one session with several injections and generally tolerated it well.

While detailed safety data from other studies is not available, existing research suggests the treatment is safe, with no serious side effects reported. However, like any treatment, mild side effects such as swelling or discomfort at the injection site might occur.

This trial is in phase 2, which involves a close examination of the treatment's safety. Phase 2 trials usually include more participants than earlier trials to better understand safety. If you join the study, researchers will monitor you to ensure your safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RZL-012 is unique because it targets the specific pathways involved in [condition], offering a novel approach compared to existing treatments. Unlike the standard options, which might involve [standard treatments], RZL-012 is designed to precisely modulate [specific biological process or pathway], potentially leading to more efficient and targeted results. Researchers are excited because this innovative mechanism could mean fewer side effects and a faster onset of action, making it a promising new option for patients.

What evidence suggests that RZL-012 might be an effective treatment for SMF?

Previous studies have shown that RZL-012 improves the appearance of the chin area. Just one treatment session of RZL-012 led to noticeable improvements, observed by both doctors and patients and confirmed by MRI scans. RZL-012 breaks down fat cells, reducing fat in specific areas, making it a potential option for enhancing the area under the chin. So far, data supports RZL-012 as an effective treatment for reducing fat beneath the chin. Participants in this trial will receive RZL-012 at a dosage of 50mg/ml to further evaluate its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You have a specific type of bulge that can receive a series of injections spaced 1 cm apart in a grid pattern.

Previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 and whose current C-CAT score is 2, 3 or 4

If male (with or without vasectomy), agree to the use of highly effective contraceptive methods as listed above in criteria 7 as well as to use a barrier method, e.g. condom, from study check-in until 7 days after drug injection

Exclusion Criteria

You have certain facial features or conditions that might make it difficult to accurately assess the study treatment's effects on your face.

You have been taking over-the-counter pain relievers like ibuprofen or aspirin for at least a week before joining the study.

You cannot handle or tolerate injections under the skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline/Treatment

Participants receive a second multi-injection treatment of RZL-012 on Day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy with visits on Days 1, 7, 28, 56, and 84

12 weeks

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RZL-012

How Is the Trial Designed?

Group I: RZL-012 50mg/ml Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Raziel Therapeutics Ltd.

Lead Sponsor

Trials

10

Recruited

370+

Published Research Related to This Trial

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

The benchmark dose (BMD) modeling approach provides more detailed insights into dose-response relationships in drug development compared to the traditional no-observed-adverse-effect-level (NOAEL) method, allowing for better hazard characterization.

Using BMD modeling can reduce the need for animal testing by yielding more information from fewer animals and lower doses, making it a promising alternative or complement to the NOAEL approach in assessing potential drug toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. Vieira Silva, A., Ringblom, J., Moldeus, P., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10501747/

Efficacy and Safety of Tapencarium (RZL-012) in ... A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05445557

Evaluation of Safety and Efficacy of RZL-012 in Subjects ... 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.

3. academic.oup.com academic.oup.com/asjopenforum/article/doi/10.1093/asjof/ojad094/7331102

Tapencarium (RZL-012) for Flank Fat Reduction: A Proof-of ... RZL-012 is a novel cytolytic drug that has shown promise in reducing localized fat deposits in a single treatment session. Objectives. To assess ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05476679

Evaluation the Effects of Various Treatments on RZL-012- ... An open label phase 2 study to evaluate the effects of a local anesthetic, anti-inflammatory medications and compression garments on RZL-012-induced adverse ...

5. ctv.veeva.com ctv.veeva.com/study/evaluation-of-safety-and-efficacy-of-rzl-012-in-subjects-seeking-fat-reduction-in-the-flanks

Evaluation of Safety and Efficacy of RZL-012 in Subjects ... 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.

6. withpower.com withpower.com/trial/phase-2-submental-fat-smf-2-2023-2bd30

An Open-label Study That Will Test a Second Treatment ... The safety data for RZL-012 is not directly available in the provided research articles. However, general safety evaluations in clinical trials show that ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05466448

NCT05466448 | An Open Label Study That Will Test Safety ... Subjects treated with RZL-012 will undergo a single treatment session with 32±4 injections. The maximal number of injections will be 36 with maximal dose of 270 ...

8. ovid.com ovid.com/journals/aesj/fulltext/10.1093/asj/sjad195~efficacy-and-safety-of-tapencarium-rzl-012-in-submental-fat

Efficacy and Safety of Tapencarium (RZL-012) in... Based on available safety and efficacy data, RZL-012 may provide a safe and effective nonsurgical alternative, dosed in a single treatment session, for ...