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

NCT05763160 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Submental Fat

Interventions

DRUG

RZL-012

Ready to use drug product for injection into the subcutaneous fat

Sponsors & Collaborators

  • Raziel Therapeutics Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2023-07-30
Completion
2023-10-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763160 on ClinicalTrials.gov