Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease

NCT03492840 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RZL-012-FD-P2aUS-001.70
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will receive RZL-012.

Conditions

Lipedema; Dercum Disease

Outcome Measures

Primary Outcomes (1)

• The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort

  Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort

  0-14 days

Study Arms (2)

Cohort 1 - Dercum's Disease

ACTIVE COMPARATOR

Nodular size - diameter (cm) 2-2.9, 3-3.9, 4-8 Total dose of RZL-012(mg) 10 15 20 Dose per NOAEL 1/25th , 1/18.75th, 1/12.5th Number of injections: 2,3,4

Drug: RZL-012

Cohort 2 - Lipedema

ACTIVE COMPARATOR

Total dose of RZL-012 (mg) 60 , 80 Dose per NOAEL: 1/4.6888, 1/3.125 Number of injections: 12, 16

Drug: RZL-012

Interventions

RZL-012 DRUG

The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites

Cohort 1 - Dercum's Disease; Cohort 2 - Lipedema

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: For lipedema - women only. For lipedema and Dercum- Post-menopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal (at least 2 years) women no more than 65 years old, with lipedema involving substantial fat above the knee or nodular Dercum's disease in such women and in men 20 - 65 years with nodular Dercum's disease.
• For Dercum's disease subjects - at least 2 nodules to be injected of at least 2cm diameter each, as determined by ultrasound
• For lipedema subjects - Significant subcutaneous fat above the knee as determined by circumference of 50cm
• Generally considered healthy according to medical history, physical examination, ECG and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration \< 100 mg, normal blood pressure).
• Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

You may not qualify if:

• Unable to tolerate subcutaneous injection.
• Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator, put the subject at significant risk, are not eligible.
• Positive blood screen for Hepatitis B surface antigen (HbSAg), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV), or positive urine screen for alcohol or drugs of abuse (unless prescribed by a physician).
• Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
• As a result of medical review, 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.

Sponsors & Collaborators

• Raziel Therapeutics Ltd.: lead
• University of Arizona: collaborator

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Lipedema; Adiposis Dolorosa

Interventions

RZL-012

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lipomatosis; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Racheli Gueta
• 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: April 10, 2018
• Study Start: June 28, 2018
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)