CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
RZL-012 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 18-65 years
  • ✓BMI ≥22 and <30
  • ✓Clearly visible and palpable flank fat with symmetrical appearance of right and left flanks
  • ✓Willing to maintain weight within 5% and avoid sun exposure for at least 1 month after each treatment
Key exclusion· 9
  • ✕Unable to tolerate subcutaneous injections
  • ✕Dysfunctional gallbladder (cholecystectomy, cholecystitis)
  • ✕Uncontrolled systemic disease (cardiovascular disease, mental illness)
  • ✕History or family history of venous thrombotic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05445557
NCT05445557Phase 2Completed
CompareCT.gov

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

Raziel Therapeutics Ltd.·interventional·Posted Jul 6, 2022·Updated Nov 18, 2023

In Brief

A Phase 2 clinical trial evaluating RZL-012 and Placebo for Flank Mass. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFlank Mass
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJul 6, 2022
Enrollment StartMar 10, 2022
Primary CompletionOct 20, 2022
Study CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.0 years ago

Interventions

RZL-012drug

small synthetic molecule for submental fat reduction

Placebodrug

Placebo