Trial · NCT04229030

RZL-012 for Dercum's Disease Lipomas

NCT04229030, Phase 2, Completed, Raziel Therapeutics Ltd.; results first posted 2024-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RZL-012 for Dercum's Disease Lipomas. Trials, record NCT04229030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04229030

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RZL-012 for Dercum's Disease Lipomas
NCT number: NCT04229030
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: Raziel Therapeutics Ltd.
Conditions: Dercum's Disease Lipomas
Interventions: RZL-012, Vehicle
First posted: 2020-01-14
Last updated: 2024-02-07
Results first posted: 2024-02-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Efficacy - Change in Lipomas Dimensions	0-84 days	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
Secondary	Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas	0-84 days	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
Secondary	Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28	0-28 days	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.
Other	Exploratory	0-84 Days	Improvement in Quality of Life - QOL questionnaire. Improvement will be measured for active vs. placebo at Day 0 and Day 84 following treatment.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Efficacy - Change in Lipomas Dimensions	0-84 days	percentage of change from baseline	MEAN
SECONDARY	Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas	0-84 days	percentage of change from baseline	MEAN
SECONDARY	Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28	0-28 days	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Exploratory	0-84 Days	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Efficacy - Change in Lipomas Dimensions	RZL-012	-15.13	Standard Deviation 25.56	percentage of change from baseline
Efficacy - Change in Lipomas Dimensions	Vehicle of RZL-012	-15.92	Standard Deviation 23.96	percentage of change from baseline
Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas	RZL-012	-56.15	Standard Deviation 35.77	percentage of change from baseline
Key Secondary Outcome - Efficacy - Improvement in Pain Assessment of Individual Lipomas	Vehicle of RZL-012	-34.34	Standard Deviation 40.15	percentage of change from baseline
Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28	RZL-012	0		Participants
Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28	Vehicle of RZL-012	0		Participants
Exploratory	RZL-012	0		Participants
Exploratory	Vehicle of RZL-012	0		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	RZL-012	20	125
Overall Study	STARTED	Vehicle of RZL-012	18	109
Overall Study	COMPLETED	RZL-012	20	125
Overall Study	COMPLETED	Vehicle of RZL-012	18	109
Overall Study	NOT COMPLETED	RZL-012	0	0
Overall Study	NOT COMPLETED	Vehicle of RZL-012	0	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Injection site bruising	General disorders	RZL-012	6	20
other	Injection site bruising	General disorders	Vehicle of RZL-012	3	18
other	Injection site discoloration	General disorders	RZL-012	5	20
other	Injection site discoloration	General disorders	Vehicle of RZL-012	0	18
other	Injection site erythema	General disorders	RZL-012	20	20
other	Injection site erythema	General disorders	Vehicle of RZL-012	17	18
other	Injection site hypesthesia	General disorders	RZL-012	2	20
other	Injection site hypesthesia	General disorders	Vehicle of RZL-012	0	18
other	Injection site edema	General disorders	RZL-012	20	20
other	Injection site edema	General disorders	Vehicle of RZL-012	18	18

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RZL-012	0	20
Total, all-cause mortality	Vehicle of RZL-012	0	18
Total, other adverse events	RZL-012	20	20
Total, other adverse events	Vehicle of RZL-012	18	18
Total, serious adverse events	RZL-012	0	20
Total, serious adverse events	Vehicle of RZL-012	0	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
RZL-012 vs Vehicle of RZL-012: Exploratory	Trial comparisons
RZL-012 vs Vehicle of RZL-012: Safety Number of Participants With One or More Abnormal Laboratory Values up to Day 28	Trial comparisons
RZL-012 vs Vehicle of RZL-012: deaths from any cause	Trial comparisons
RZL-012 vs Vehicle of RZL-012: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04229030

GET https://conductscience.org/api/trials/v1/NCT04229030/registered

API reference For AI assistants