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RZL-012 for Dercum's Disease Lipomas
Phase 2 trial testing RZL-012 in Dercum's Disease Lipomas in 38 participants. Completed in 20 February 2021.
| Lead sponsor | Raziel Therapeutics Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 30 July 2020 |
| Primary completion | 20 February 2021 |
| Estimated completion | 20 February 2021 |
| Sites | 1 location across United States |
Raziel Therapeutics Ltd. — full company profile →
Adults 18 to 70, any sex, with Dercum's Disease Lipomas. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| RZL-012 | -15.13 | ± 25.56 |
| Vehicle of RZL-012 | -15.92 | ± 23.96 |
Assessment of lipoma/nodule associated pain using the Comparative Pain Scale. 0 is "no pain" and 10 is "worst pain". Pain measured for active vs. placebo at days 28,56,84
| Group | Value | 95% CI |
|---|---|---|
| RZL-012 | -56.15 | ± 35.77 |
| Vehicle of RZL-012 | -34.34 | ± 40.15 |
Safety will be assessed by by change-from-baseline values for clinical laboratory tests. measured for active vs. placebo at days 1 and 28 following injection. Number of subjects with abnormal laboratory values will be compared in both study arms.
| Group | Value | 95% CI |
|---|---|---|
| RZL-012 | 0 | |
| Vehicle of RZL-012 | 0 |
Improvement in Quality of Life - QOL questionnaire. Improvement will be measured for active vs. placebo at Day 0 and Day 84 following treatment.
| Group | Value | 95% CI |
|---|---|---|
| RZL-012 | 0 | |
| Vehicle of RZL-012 | 0 |
Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | RZL-012 | Vehicle of RZL-012 |
|---|---|---|---|
| Injection site erythema | General disorders | — | — |
| Injection site edema | General disorders | — | — |
| Injection site pain | General disorders | — | — |
| Injection site pruritus | General disorders | — | — |
| Injection site bruising | General disorders | — | — |
| Injection site discoloration | General disorders | — | — |
| Injection site hypesthesia | General disorders | — | — |
Data from ClinicalTrials.gov NCT04229030 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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