An Open-label Study That Will Test a Second Treatment Session of RZL-012.

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves giving additional RZL-012 injections under the chin to people who have previously participated. The goal is to further reduce fat and improve appearance by breaking down fat cells, which the body then removes.

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.

What safety data exists for the treatment known as RZL-012?

The safety data for RZL-012 is not directly available in the provided research articles. However, general safety evaluations in clinical trials show that adverse events can occur, with headaches being common, but severe events are rare. No deaths or life-threatening events were reported in the studies mentioned. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

Interventions

• RZL-012

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

New Associations between Drug-Induced Adverse Events in Animal Models and Humans Reveal Novel Candidate Safety Targets. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]