Trial Outcomes & Findings for An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects. (NCT NCT05466448)

Results Overview

Measurement of maximum drug concentration (Cmax) (ng/mL)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

48 hours

Results posted on

2023-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Chinese RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Overall Study STARTED	6	9
Overall Study COMPLETED	5	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Chinese Subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chinese n=6 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Total n=15 Participants Total of all reporting groups
Age, Continuous	34.5 Years STANDARD_DEVIATION 14.7 • n=5 Participants	43.8 Years STANDARD_DEVIATION 11.9 • n=7 Participants	40.1 Years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Measurement of maximum drug concentration (Cmax) (ng/mL)

Outcome measures

Outcome measures
Measure	Chinese n=6 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)	487.7 concentration (ng/ml) Standard Deviation 183.6	473.3 concentration (ng/ml) Standard Deviation 186.8

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Chinese n=6 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Pharmacokinetics Measure - Area Under the Plasma Concentration Versus Time Curve (AUC) (mg*h/L)	4574.4 AUC to Last Nonzero Conc (mg*h/L) Standard Deviation 987.7	4718.0 AUC to Last Nonzero Conc (mg*h/L) Standard Deviation 1345.1

SECONDARY outcome

Timeframe: 84 days

To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Clinician Chin Assessment Tool (C-CAT) by proportion of subjects with reduction in C-CAT score. The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck

Outcome measures

Outcome measures
Measure	Chinese n=5 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Efficacy -Change in Score According to Clinician Chin Assessment Tool (C-CAT)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 84 days

To determine the efficacy of RZL-012 versus placebo on submental fat (SMF) reduction measured on Day 84 versus baseline using the Subject Chin Assessment Tool (S-CAT) by proportion of subjects who has reduction in S-CAT score. The CAT is composed of 5 points where 0 represents no fat and 4 represent very noticeable bulge and fat that extends beyond the neck

Outcome measures

Outcome measures
Measure	Chinese n=5 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Efficacy - Change in Score According to Subject Chin Assessment Tool (S-CAT)	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 84 days

Change from baseline in submental fat thickness (%), as measured with MRI in RZL-012 treated subjects vs. placebo treated subjects on Day 84 following injection

Outcome measures

Outcome measures
Measure	Chinese n=5 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Efficacy - Change in Submental Fat Thickness	-34.3 percentage of thickness reduction Standard Deviation 17.2	-24.6 percentage of thickness reduction Standard Deviation 23

SECONDARY outcome

Timeframe: 84 days

To evaluate the safety of RZL-012 subcutaneous injections in the submental area in Chinese vs. non Chinese population, as assessed by spontaneous adverse event reports and post injection evaluation of treatment area. Treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus. The number of subjects with treatment-related adverse events will be compared within each treatment group, as assessed by CTCAE v4.0

Outcome measures

Outcome measures
Measure	Chinese n=6 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 Participants RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Safety - Adverse Events Follow up	6 Participants	9 Participants

Adverse Events

Chinese

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Non-Chinese

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chinese n=6 participants at risk RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012	Non-Chinese n=9 participants at risk RZL-012 50mg/ml small synthetic molecule for submental fat reduction RZL-012: concentration of injected formulation 50 mg/mL RZL-012 of 7.5 mg/0.15 mL/injection point that results in a maximum total dose/volume of 240±30 mg/4.8±0.6 mL RZL-012
Gastrointestinal disorders Dysphagia	50.0% 3/6 • 3 months	22.2% 2/9 • 3 months
Gastrointestinal disorders Nausea	0.00% 0/6 • 3 months	11.1% 1/9 • 3 months
General disorders Injection site erythema	0.00% 0/6 • 3 months	77.8% 7/9 • 3 months
General disorders Injection site haemorrhage	33.3% 2/6 • 3 months	55.6% 5/9 • 3 months
General disorders Injection site hypoaesthesia	0.00% 0/6 • 3 months	44.4% 4/9 • 3 months
General disorders Injection site edema	100.0% 6/6 • 3 months	100.0% 9/9 • 3 months
General disorders Injection site pain	100.0% 6/6 • 3 months	100.0% 9/9 • 3 months
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • 3 months	33.3% 3/9 • 3 months
Skin and subcutaneous tissue disorders Skin induration	66.7% 4/6 • 3 months	55.6% 5/9 • 3 months

Additional Information

Racheli Gueta

Raziel Therapeutics

Phone: 97289126941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place