NCT03171415 is a Phase 2 clinical trial of RZL-012 in Obesity, sponsored by Raziel Therapeutics Ltd..

Who is sponsoring NCT03171415?

NCT03171415 is sponsored by Raziel Therapeutics Ltd..

What drugs are being tested in NCT03171415?

Interventions in NCT03171415: RZL-012, Placebo.

What condition does NCT03171415 study?

NCT03171415 studies Obesity, Weight Loss, Overweight and Obesity.

Is NCT03171415 still recruiting?

NCT03171415 is currently completed. Last updated 21 August 2019.

Are results published for NCT03171415?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-21 · How we verify

NCT03171415

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers

Completed Phase 2 Results posted Last updated 21 August 2019

What this trial tests

Phase 2 trial testing RZL-012 in Obesity in 32 participants. Completed in 28 December 2018.

Timeline

25 July 2017

Primary endpoint
28 December 2018

28 December 2018

Quick facts

Lead sponsor	Raziel Therapeutics Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	25 July 2017
Primary completion	28 December 2018
Estimated completion	28 December 2018
Sites	1 location across United States

Drugs / interventions tested

RZL-012 — full drug profile →
Placebo

Conditions studied

Obesity — all drugs for Obesity →
Weight Loss — all drugs for Weight Loss →
Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Raziel Therapeutics Ltd. — full company profile →

Who can join

Adults 20 to 60, male only, with Obesity or Weight Loss. 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.

Safety: The Incidence of Treatment-related Adverse Events [AEs] Primary · 0-168 days

AEs will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)AEs incidence will be by body system, seriousness, severity and relation to study drug by cohort.

Serious Adverse Events

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	0

Other Adverse Events

Group	Value	95% CI
RZL-012 Cohort 1	6
RZL-012 Cohort 2	6
RZL-012 Cohort 3	6
RZL-012 Cohort 4	6
Placebo	9

Cardiac disorder ventricular extrasystoles

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	1

Ear and labyrinth disorders - Ear pain

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	1

Ear and labyrinth disorders Ear swelling

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	1

Ear and labyrinth disorders - Hypoacusis

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	1

Ear and labyrinth disorders otorrhoea

Group	Value	95% CI
RZL-012 Cohort 1	0
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	2

Aministration site condition - energy uncreased

Group	Value	95% CI
RZL-012 Cohort 1	1
RZL-012 Cohort 2	0
RZL-012 Cohort 3	0
RZL-012 Cohort 4	0
Placebo	0

Efficacy: A Significant Thermogenesis at the Injected Site. Primary · 28-168 days

Thermogenesis is measured by thermal imaging is non-invasive, non-radiating Infra-Red thermal camera that passively measures the emitting infra-red radiation of body surface. Difference in temperatures between the sites (treated - not treated) by visit treatment along with the change from baseline (net-delta) in these differences by cohort and overall. Significant thermogenesis is defined as net-delta ≥ 1. Outcome measure data table represents the number of subjects who demonstrated an increase that is higher than 1 celsius degree.

Day 28

Group	Value	95% CI
RZL-012 Cohort 1	5
RZL-012 Cohort 2	5
RZL-012 Cohort 3	3
RZL-012 Cohort 4	6
Placebo	1

Day 56

Group	Value	95% CI
RZL-012 Cohort 1	1
RZL-012 Cohort 2	3
RZL-012 Cohort 3	3
RZL-012 Cohort 4	6
Placebo	0

Day 84

Group	Value	95% CI
RZL-012 Cohort 1	NA
RZL-012 Cohort 2	NA
RZL-012 Cohort 3	NA
RZL-012 Cohort 4	4
Placebo	0

Day 112

Group	Value	95% CI
RZL-012 Cohort 1	NA
RZL-012 Cohort 2	NA
RZL-012 Cohort 3	NA
RZL-012 Cohort 4	5
Placebo	0

Day 140

Group	Value	95% CI
RZL-012 Cohort 1	NA
RZL-012 Cohort 2	NA
RZL-012 Cohort 3	NA
RZL-012 Cohort 4	4
Placebo	0

Day 168

Group	Value	95% CI
RZL-012 Cohort 1	NA
RZL-012 Cohort 2	NA
RZL-012 Cohort 3	NA
RZL-012 Cohort 4	3
Placebo	0

Duration of the Thermogenic Effect From Day 28. Secondary · 28-168 days

The duration of the thermogenic effect for subjects in the active arm with thermogenic effect (net-delta ≥ 1) by visit and cohort.

Group	Value	95% CI
RZL-012 Cohort 1	5.6	± 12.5
RZL-012 Cohort 2	16.8	± 15.3
RZL-012 Cohort 3	5.6	± 12.5
RZL-012 Cohort 4	107.3	± 44.9
Placebo	0	± 0

Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen. Secondary · 28-168 days

Subcutaneous Fat Mass (SFM) ratio (treated sites / control sites) averaged over the MRI slices by visit, treatment and cohort and the change from baseline in SFM ratio (in % from the ratio at baseline) compared between the treatment arms.

Day 28

Group	Value	95% CI
RZL-012 Cohort 1	-0.62	± 5.17
RZL-012 Cohort 2	-9.15	± 10.55
RZL-012 Cohort 3	-9.1	± 4.27
RZL-012 Cohort 4	-14.68	± 8.16
Placebo	2.94	± 10.08

Day 56

Group	Value	95% CI
RZL-012 Cohort 1	NA	± NA
RZL-012 Cohort 2	-8.56	± 8.85
RZL-012 Cohort 3	-10.52	± 8.42
RZL-012 Cohort 4	-18.10	± 10.93
Placebo	3.61	± 3.48

Day 84

Group	Value	95% CI
RZL-012 Cohort 1	NA	± NA
RZL-012 Cohort 2	NA	± NA
RZL-012 Cohort 3	NA	± NA
RZL-012 Cohort 4	-12.75	± 9.83
Placebo	-6.57	± 9.78

Day 112

Group	Value	95% CI
RZL-012 Cohort 1	NA	± NA
RZL-012 Cohort 2	NA	± NA
RZL-012 Cohort 3	NA	± NA
RZL-012 Cohort 4	-16.10	± 13.81
Placebo	-8.2	± 11.54

Day 140

Group	Value	95% CI
RZL-012 Cohort 1	NA	± NA
RZL-012 Cohort 2	NA	± NA
RZL-012 Cohort 3	NA	± NA
RZL-012 Cohort 4	-12.46	± 11.26
Placebo	-2.9	± 0.45

Day 168

Group	Value	95% CI
RZL-012 Cohort 1	NA	± NA
RZL-012 Cohort 2	NA	± NA
RZL-012 Cohort 3	NA	± NA
RZL-012 Cohort 4	-14.32	± 10.94
Placebo	-2.54	± 8.57

Changes in Fasting Blood Glucose From Baseline. Secondary · 56 days

Changes from baseline in fasting blood glucose by visit, treatment, and cohort.

Day -1

Group	Value	95% CI
RZL-012 Cohort 1	86.7	± 4.2
RZL-012 Cohort 2	91.3	± 5.16
RZL-012 Cohort 3	91.7	± 7.47
RZL-012 Cohort 4	90.8	± 7.17
Placebo	93.2	± 3.93

Day 56

Group	Value	95% CI
RZL-012 Cohort 1	93	± 3.22
RZL-012 Cohort 2	92.8	± 11.8
RZL-012 Cohort 3	93.3	± 7.58
RZL-012 Cohort 4	93.7	± 5.3
Placebo	94.6	± 6.6

Changes in Blood Lipid Profile From Baseline. Secondary · 56 days

Changes from baseline in lipid profile by visit, treatment, and cohort.

Cholesterol Day -1

Group	Value	95% CI
RZL-012 Cohort 1	188	± 32.8
RZL-012 Cohort 2	199	± 11
RZL-012 Cohort 3	196	± 41.4
RZL-012 Cohort 4	170.8	± 23
Placebo	186.7	± 19.8

Cholesterol Day 56

Group	Value	95% CI
RZL-012 Cohort 1	184	± 39.8
RZL-012 Cohort 2	205	± 29.7
RZL-012 Cohort 3	201.7	± 46.1
RZL-012 Cohort 4	176	± 28.6
Placebo	182.4	± 19.3

HDL Day -1

Group	Value	95% CI
RZL-012 Cohort 1	43.5	± 7.23
RZL-012 Cohort 2	44.33	± 11.1
RZL-012 Cohort 3	41.5	± 6
RZL-012 Cohort 4	44	± 6.87
Placebo	42.44	± 5.6

HDL Day 56

Group	Value	95% CI
RZL-012 Cohort 1	40	± 9.44
RZL-012 Cohort 2	50.8	± 14.2
RZL-012 Cohort 3	41.5	± 9.9
RZL-012 Cohort 4	45.3	± 5.05
Placebo	41.14	± 7

LDL Day -1

Group	Value	95% CI
RZL-012 Cohort 1	129	± 33.5
RZL-012 Cohort 2	126.5	± 13.3
RZL-012 Cohort 3	134	± 33
RZL-012 Cohort 4	105.5	± 15
Placebo	116	± 10.3

LDL Day 56

Group	Value	95% CI
RZL-012 Cohort 1	120	± 31.3
RZL-012 Cohort 2	132	± 23.9
RZL-012 Cohort 3	134.7	± 37
RZL-012 Cohort 4	128	± 0
Placebo	103	± 14.8

Triglycerides Day -1

Group	Value	95% CI
RZL-012 Cohort 1	107.3	± 42.3
RZL-012 Cohort 2	131	± 77
RZL-012 Cohort 3	112.5	± 58.9
RZL-012 Cohort 4	121.7	± 39.3
Placebo	155.8	± 98

Triglycerides Day 56

Group	Value	95% CI
RZL-012 Cohort 1	118	± 85.4
RZL-012 Cohort 2	136	± 61.1
RZL-012 Cohort 3	193.5	± 16.7
RZL-012 Cohort 4	128.33	± 55.4
Placebo	234	± 220

Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012. Secondary · 1-2 days

Averaged Cmax values by cohort.

Group	Value	95% CI
RZL-012 Cohort 1	84.15	± 16.27
RZL-012 Cohort 2	181.89	± 49.86
RZL-012 Cohort 3	241	± 72.09
RZL-012 Cohort 4	344	± 73.7

Changes in Body Weight Secondary · 56 days

Changes from baseline in body weight by visit, treatment, and cohort.

Weight Day -1

Group	Value	95% CI
RZL-012 Cohort 1	103.3	± 11.1
RZL-012 Cohort 2	95.4	± 6.9
RZL-012 Cohort 3	101.3	± 20.3
RZL-012 Cohort 4	96.1	± 12.6
Placebo	99.1	± 8.1

Weight Day 56

Group	Value	95% CI
RZL-012 Cohort 1	104.4	± 12.5
RZL-012 Cohort 2	96.1	± 7.8
RZL-012 Cohort 3	103.4	± 22.4
RZL-012 Cohort 4	96	± 12.3
Placebo	101.2	± 9.7

Changes in Waist to Hip Ratio [WHR] Secondary · 56 days

Changes from baseline in WHR by visit, treatment, and cohort. WHR is calculated by measurements of waist circumference and hip circumference.

Waist to hip ratio Day -1

Group	Value	95% CI
RZL-012 Cohort 1	1	± 0.1
RZL-012 Cohort 2	1	± 0
RZL-012 Cohort 3	1	± 0.1
RZL-012 Cohort 4	1	± 0
Placebo	1	± 0.1

Waist to hip ratio Day 56

Group	Value	95% CI
RZL-012 Cohort 1	1	± 0
RZL-012 Cohort 2	1	± 0
RZL-012 Cohort 3	1	± 0
RZL-012 Cohort 4	1	± 0
Placebo	1	± 0.1

Elucidation of the Histological Changes Account for the Thermogenic Effect. Secondary · 56 days

An abdominal subcutaneous adipose tissue biopsy will be taken from the injected side. Histology results will be assessed for 2 subjects who were injected with 120 mg RZL-012 and for one subject who was injected with placebo.

Group	Value	95% CI
RZL-012 Cohort 3	2
Placebo	1

Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling. Secondary · 28 days

Changes from baseline in inflammatory markers and cytokines by visit, treatment, and cohort. Testing of inflammatory markers and cytokines will be conducted by blood sampling.

CRP Day -1 (mg/dL)

Group	Value	95% CI
RZL-012 Cohort 2	0.2	± 0.13
RZL-012 Cohort 3	0.6	± 1.08
RZL-012 Cohort 4	0.5	± 0
Placebo	0.2	± 0.1

CRP Day 28 (mg/dL)

Group	Value	95% CI
RZL-012 Cohort 2	0.27	± 0.31
RZL-012 Cohort 3	0.2	± 0.12
RZL-012 Cohort 4	0.43	± 0.15
Placebo	0.2	± 0.1

Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012. Secondary · 0.5, 1,2,3,4,5,6,8,12,16,24,30 hours

Averaged Tmax values by cohort.

Group	Value	95% CI
RZL-012 Cohort 1	1.83	± 0.41
RZL-012 Cohort 2	1.83	± 0.41
RZL-012 Cohort 3	1.83	± 0.41
RZL-012 Cohort 4	2	± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RZL-012 Cohort 1

Serious: 0/6 (0%)

Deaths: 0/6

RZL-012 Cohort 2

Serious: 0/6 (0%)

Deaths: 0/6

RZL-012 Cohort 3

Serious: 0/6 (0%)

Deaths: 0/6

RZL-012 Cohort 4

Serious: 0/6 (0%)

Deaths: 0/6

Placebo

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (33 terms — click to expand)

Reaction	System	RZL-012 Cohort 1	RZL-012 Cohort 2	RZL-012 Cohort 3	RZL-012 Cohort 4	Placebo
Injection site Erythema	General disorders	—	—	—	—	—
Injection site Edema	General disorders	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—
Injection site warmth	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—	—
ear pain	Ear and labyrinth disorders	—	—	—	—	—
ear swelling	Ear and labyrinth disorders	—	—	—	—	—
Hypoacusis	Ear and labyrinth disorders	—	—	—	—	—
Otorrhoea	Ear and labyrinth disorders	—	—	—	—	—
Energy increased	General disorders	—	—	—	—	—
fatigue	General disorders	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—
Injection site discolouration	General disorders	—	—	—	—	—
Injection site hemmorhage	General disorders	—	—	—	—	—
Injection site mass	General disorders	—	—	—	—	—
Injection site nodule	General disorders	—	—	—	—	—
Injection site rash	General disorders	—	—	—	—	—
Medical device reaction	General disorders	—	—	—	—	—
Non cardiac chest pain	General disorders	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—
Electrocardiac QT prolonged	Investigations	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Orpharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT03171415 adverse events section.

Sponsor's own description

Obesity is a direct result of food-intake in excess of body energy expenditure. Thus, induction of increased energy expenditure via the activation of thermogenesis at targeted anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel compound, in treating obesity by activating thermogenesis in subcutaneous fat.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Small molecules for fat combustion: targeting obesity.
Liu J, Wang Y, Lin L. · · 2019 · cited 91× · PMID 30976490 · DOI 10.1016/j.apsb.2018.09.007
Differential Diagnosis of a Case of Dercum's Disease with Possible Familial Involvement and Review of Literature.
Li LZ, Kan CFK, Webb-Detiege TA. · · 2021 · cited 3× · PMID 34970098
Clinical Application Potential of Small Molecules that Induce Brown Adipose Tissue Thermogenesis by Improving Fat Metabolism.
Lu KY, Primus Dass KT, Tsai SF, Chuang HM, et al · · 2020 · cited 2× · PMID 32854518 · DOI 10.1177/0963689720927394

Verify or expand the search:

Other trials of RZL-012

Trials testing the same drug.

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
NCT04867434 — Efficacy and Safety of RZL-012 on Submental Fat Reduction · Phase 2 · completed

Other recruiting trials for Obesity

Currently open trials in the same condition.

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NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting

Other Raziel Therapeutics Ltd. trials

Trials by the same sponsor.

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
NCT04867434 — Efficacy and Safety of RZL-012 on Submental Fat Reduction · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03171415 (US National Library of Medicine, public domain)
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: 21 August 2019

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/NCT03171415.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03171415

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of RZL-012

Other recruiting trials for Obesity

Other Raziel Therapeutics Ltd. trials

Verify against primary sources