Adults 18 to 65, any sex, with Submental Fat. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy -Proportion of Subjects With at Least a 1-grade Improvement in the C-CAT Scale at Day 84Primary· 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). 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
Group
Value
95% CI
RZL-012 50mg/ml
43
RZL-012 34mg/ml
39
Placebo
27
Efficacy - the Proportion of Subjects With at Least 1-grade Improvement in Subject Chin Assessment Tool (S-CAT)Secondary· 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). 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
Group
Value
95% CI
RZL-012 50mg/ml
43
RZL-012 34mg/ml
42
Placebo
30
Efficacy - Relative Change in Submental Fat Volume on Day 84 vs. BaselineSecondary· 84 days
Percent reduction from baseline in submental fat volume , as measured with MRI in RZL-012 treated subjects vs. placebo treated subjects on Day 84 following injection vs. baseline.
Group
Value
95% CI
RZL-012 50mg/ml
-14.92
± 9.98
RZL-012 34mg/ml
-8.34
± 11.72
Placebo
1.45
± 8.68
Safety - Adverse Events Follow upSecondary· 84 days
To evaluate the safety of RZL-012 subcutaneous injections in the submental area, relative to placebo, 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.
Dysphagia
Group
Value
95% CI
RZL-012 50mg/ml
15
RZL-012 34mg/ml
21
Placebo
2
Injection site edema
Group
Value
95% CI
RZL-012 50mg/ml
21
RZL-012 34mg/ml
27
Placebo
27
Injection site bruising
Group
Value
95% CI
RZL-012 50mg/ml
18
RZL-012 34mg/ml
17
Placebo
20
Injection site erythema
Group
Value
95% CI
RZL-012 50mg/ml
7
RZL-012 34mg/ml
4
Placebo
3
Injection site hemorrhage
Group
Value
95% CI
RZL-012 50mg/ml
6
RZL-012 34mg/ml
10
Placebo
7
Injection site hypoesthesia
Group
Value
95% CI
RZL-012 50mg/ml
15
RZL-012 34mg/ml
15
Placebo
12
Injection site mass
Group
Value
95% CI
RZL-012 50mg/ml
5
RZL-012 34mg/ml
4
Placebo
1
Injection site pain
Group
Value
95% CI
RZL-012 50mg/ml
34
RZL-012 34mg/ml
31
Placebo
23
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A total of 135 eligible male or female subjects will be randomized according to a predetermined randomization scheme (1:1:1 ratio) to receive a single multi-injection treatment of high dose RZL-012, low dose RZL-012, or placebo on Day 0. They will be monitored for safety and efficacy over 84 days.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT05763160 — An Open-label Study That Will Test a Second Treatment Session of RZL-012.
· Phase 2
· completed
NCT05476679 — Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
· Phase 1, PHASE2
· completed
NCT05466448 — An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Ch
· Phase 1, PHASE2
· completed
NCT05445557 — Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
· Phase 2
· completed
NCT05763160 — An Open-label Study That Will Test a Second Treatment Session of RZL-012.
· Phase 2
· completed
NCT05476679 — Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events
· Phase 1, PHASE2
· completed
NCT05466448 — An Open Label Study That Will Test Safety and Efficacy of RZL-012 Injection Into the Submental Fat in Chinese vs. Non-Ch
· Phase 1, PHASE2
· completed
NCT05445557 — Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Raziel Therapeutics Ltd.
Last refreshed: 28 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04867434.