RZL-012 for Dercum's Disease Lipomas

NCT04229030 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-DD-P2bUS-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Thirty-eight (38) subjects will be included in the study. Subjects will be randomized in a ration of 1:1 to be treated with RZL-012 or placebo. Subjects will be injected with a different doses of RZL-012 according to their lipomas sizes. The total of 38 subjects will be enrolled in 3 clinical sites.

Conditions

Dercum's Disease Lipomas

Outcome Measures

Primary Outcomes (1)

• Efficacy - Change in Lipomas Dimensions

  Evaluation of the efficacy of RZL-012 following injection into lipomas/nodules of Dercum's Disease (DD) subjects. Efficacy will be determined by ultrasound assessment of the lipoma/nodule dimensions after treatment vs baseline. Lipomas Dimensions will be measured for active vs. placebo at days 28,56,84

  0-84 days

Secondary Outcomes (2)

• Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas

  0-84 days

• Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28

  0-28 days

Other Outcomes (1)

• Exploratory

  0-84 Days

Study Arms (2)

RZL-012

ACTIVE COMPARATOR

A single-treatment injection, multiple subcutaneous injections of RZL-012 administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL RZL-012 (5mg). Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL RZL-012 (20mg). 4-5.9 cm will be dozed with 0.8mL RZL-012 (80mg). 6-7.9 cm will be dozed with 1 mL RZL-012 (100mg). 8-10 cm will be dozed with 1.2 mL RZL-012 (120mg).

Drug: RZL-012

Vehicle of RZL-012

PLACEBO COMPARATOR

A single-treatment injection, multiple subcutaneous injections of vehicle administered into 4-8 lipomas in each subject, preferably 6. Dosing will be done according to lipomas size, as will be determined by Ultrasound. Each injection contains 0.1mL vehicle. Lipomas in the size of: 2-3.9 cm will be dozed with 0.4mL vehicle. 4-5.9 cm will be dozed with 0.8mL vehicle. 6-7.9 cm will be dozed with 1 mL vehicle. 8-10 cm will be dozed with 1.2 mL vehicle.

Drug: Vehicle

Interventions

RZL-012 DRUG

small synthetic molecule for the treatment of Dercum's Disease lipomas

RZL-012

Vehicle DRUG

Vehicle of RZL-012 drug product

Also known as: placebo

Vehicle of RZL-012

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 4 painful lipomas of appropriate size to be injected on a background of Dercum's Disease.
• Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG) and laboratory evaluation with an emphasis on metabolic parameters (fasting glucose concentration \< 200 mg/dL).
• Subjects must be able to adhere to the visit schedule and protocol requirements and be capable of completing the study.
• Males or females in the age of fertility are willing to refrain from sexual activity or agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
• Subjects must sign an informed consent indicating they are aware of the investigational nature of the study.

You may not qualify if:

• Unable to tolerate subcutaneous injections.
• Pregnant women.
• Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator places the subject at significant risk.
• Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).
• Subjects with a clinical history of active primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids
• Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
• As a result of medical review and physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
• Known sensitivity to components of the injection formulation.
• Prior wound, tattoo or infection in the treated area.
• Prior invasive treatment such as surgery or injectable drug at the RZL-012 injected area.
• Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
• Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
• Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead

Study Sites (1)

Limitless Therapeutics

Los Angeles, California, 90025, United States

Location

MeSH Terms

Interventions

RZL-012

Results Point of Contact

• Title: Racheli Gueta, Director of Clinical trials
• Organization: Raziel Therapeutics

racheli@raziel-therapy.com

97289126941

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: July 30, 2020
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)