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

Status Completed

Clinical Trial Summary

This is a Phase 2, open-label study in which subjects seeking further improvement of their SMF will be treated with a second treatment session of RZL-012. The second treatment session will be offered to subjects previously treated with RZL-012 under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to participate in the new trial. For each subject, the study will consist of a screening period, baseline period in which subjects will receive a second treatment session of RZL-012 and a follow-up period. RZL-012 will be administered during a single treatment session via multiple injections into the submental area under the chin. Subjects will thereafter be monitored for safety and efficacy for at least 84 days.

Clinical Trial Description

Screening Period: Subjects will be eligible to undergo screening after successful completion of (defined as completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001 studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the screening period, subjects will be assessed for study eligibility by evaluation of subjects' SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography. Day 0/Baseline: Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be recorded. Subjects will be asked about their pain levels using VAS. Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7, 28, 56 and 84 for efficacy and safety assessments. Safety assessments will include vital signs, labs, AEs severity assessment, and treatment area evaluation. Treatment area evaluations will include evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant medications will be recorded. ;

Study Design

Related Conditions & MeSH terms

Submental Fat

Clinical Trial Details

NCT number	NCT05763160
Study type	Interventional
Source	Raziel Therapeutics Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	May 29, 2023
Completion date	October 20, 2023

View Details

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT05154955` - A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat	Phase 2
Completed	`NCT04258761` - A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")	Phase 2
Completed	`NCT03946592` - Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat	Phase 3
Completed	`NCT04867434` - Efficacy and Safety of RZL-012 on Submental Fat Reduction	Phase 2
Completed	`NCT05466448` - An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.	Phase 1/Phase 2
Completed	`NCT04086823` - A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.	Phase 2
Completed	`NCT02159729` - Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101	Phase 2
Completed	`NCT05195112` - Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat	Phase 3
Completed	`NCT03005717` - Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat	Phase 2
Completed	`NCT02163902` - Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101	Phase 3
Completed	`NCT05476094` - Evaluate Pharmacokinetic/Pharmacodynamic and Safety/Tolerability of AYP-101 in Healthy Subjects	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.