NCT05445557

Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Raziel Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Flank Mass

Interventions

Type	Name	Description
DRUG	RZL-012	small synthetic molecule for submental fat reduction
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-10-20
• Completion: 2022-11-10
• First posted: 2022-07-06
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study