Clinical trial NCT04229030: RZL-012 for Dercum's Disease Lipomas
Official title: A Double Blind, Randomized, Multi-Center, Placebo-Controlled Phase 2B Clinical Trial for the Evaluation of Efficacy and Safety of RZL-012 in Subjects Having Dercum's Disease Lipomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dercum's Disease Lipomas
Lead sponsor: Raziel Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a multi-center, randomized, double blind, placebo controlled clinical trial in DD subjects having lipomas. Subjects will be randomized, in a 1:1 ratio, into two groups injected with either RZL-012 or vehicle.

Once the study ends and codes are opened, 84 days after dosing, placebo-treated subjects will be offered the option of receiving treatment with RZL-012 and followed up for an additional 84 days.

At least 4 lipomas/nodules, preferably 6, and no more than 8, will be injected per subject, two of which will be medium (4-5.9 cm), large (6-7.9 cm) or extra-large (8-10 cm) in diameter. Dosing will be according to lipoma size, where the total injected dose will not exceed 240 mg per patient (48 injections at 5mg/injection).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy - Change in Lipomas Dimensions
timeFrame: 0-84 days
Secondary outcomes:
measure: Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas
timeFrame: 0-84 days
measure: Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28
timeFrame: 0-28 days
Other outcomes:
measure: Exploratory
timeFrame: 0-84 Days
Locations:
city: Los Angeles
country: United States
facility: Limitless Therapeutics
state: California
Study officials:
References: