Clinical Trials Logo

Clinical Trial Summary

A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days.

Clinical Trial Description

Each subject will be randomized to either active treatment (high or low dose RZL-012) or placebo at a ratio of 1:1:1 per group and receive one of the following: - low dose (concentration of injected solution 34 mg/mL RZL-012) of 5.1 mg/0.15 mL/injection point that results in a dose/volume of 163.2±20.4 mg/4.8±0.6 mL RZL-012, - high dose (concentration of injected solution 50 mg/mL RZL-012) of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012, - placebo of 0.15 mL/injection point that results in a total maximum volume of 4.8±0.6 mL. 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 doses of 183.6 mg and 270 mg for the low and high doses, respectively. Each injection point will be dosed with 5.1 mg RZL-012 for the low dose or 7.5 mg for the high dose in a volume of 0.15 mL/injection site. Placebo (vehicle) subjects will be injected with a 0.15 mL vehicle per each injection site. The maximal injection volume for all groups will be up to 5.4 mL. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04867434
Study type Interventional
Source Raziel Therapeutics Ltd.
Contact Racheli Gueta, PhD
Phone 972-8-9126941
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date May 2021
Completion date November 2021

See also
  Status Clinical Trial Phase
Completed NCT04144049 - A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat Phase 2
Active, not recruiting NCT04258761 - A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin") Phase 2
Recruiting NCT03946592 - Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat Phase 3
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 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