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CompletedNCT03171415Updated Aug 21, 2019Results posted

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

A Phase 2 interventional study of RZL-012 and Placebo in Obesity, Weight Loss and Overweight and Obesity, sponsored by Raziel Therapeutics Ltd.. Completed at 1 site in United States. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Raziel Therapeutics Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Male
01

Study summary

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.

Read the detailed description

Obesity is a direct result of food-intake in excess of body energy expenditure. Therefore, a feasible approach to combat obesity is via energy-consuming activities, such as physical exercise. Unfortunately, our modern society is moving in the other direction, spending more time in immobilized positions, at work and at home. An alternative strategy for the induction of increased energy expenditure is via the activation of thermogenic cells that utilize fat to produce heat.RZL-012 is a novel molecule that enables de-novo generation of thermogenic tissue at favorable anatomical sites. As a result, the extra fat accumulated in obese persons will be turned into heat. This is a double blind, randomized, placebo controlled, dose escalation Phase 2a clinical trial for the evaluation of safety, efficacy and thermogenesis-induction of RZL-012 in overweight and obese volunteers. This trial aims to study the ability of RZL-012 in treating obesity via the induction of thermogenic foci in subcutaneous fat.

02

Conditions studied

  • Obesity
  • Weight Loss
  • Overweight and Obesity

Keywords

  • Obesity
  • Overweight
  • Thermogenesis
  • Fat reduction
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 32 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Raziel Therapeutics Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult male subjects, 20-60 years old.
  2. Subject is considered overweight and obese, with 27.5 \< BMI ≤ 34.9.
  3. Significant subcutaneous abdominal fat as defined by Waist to hip ratio (WHR) ≥ 0.9.
  4. Subjects with stable weight in the last 3 months by medical history.
  5. Not one of the following eating disorders by subject's declaration: anorexia nervosa, bulimia nervosa.
  6. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG) and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration \< 100 mg, normal blood pressure).
  7. Subject is willing to refrain from sexual activity or agrees to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
  8. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
  9. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects weighing less than 75 kg.
  2. Subjects who have reduced/gained weight more than 5% of their current body weight in the last 3 months.
  3. Unable to tolerate subcutaneous injection.
  4. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
  5. Subjects who test positive to either Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) are not eligible.
  6. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
  7. As a result of medical review, physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
  8. Medication use on regular basis.
  9. Positive drug and alcohol tests.
  10. Known sensitivity to components of the injection formulation.
  11. Prior wound, tattoo or infection in the treated area.
  12. Excessive growth of hair in the abdomen region.
  13. Claustrophobia or MRI incompatible device or implant.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    RZL-012

    A single-time injection, multiple subcutaneous injections of RZL-012 administered into 8-36 sites (0.1mL per site): 1. 40mg RZL-012 -administered at 8 sites 2. 80mg RZL-012 - administered at 16 sites 3. 120mg RZL-012 - administered at 24 sites 4. 180mg RZL-012 - administered at 36 sited

    Drug: RZL-012

  • Placebo comparator
    Placebo

    A single-time injection, multiple subcutaneous injections of Placebo administered into 8-36 sites (0.1mL per site)

    Drug: Placebo

Interventions

  • DrugRZL-012

    Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

  • DrugPlacebo

    Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

06

What researchers measure

Primary outcomes

  1. Safety: The Incidence of Treatment-related Adverse Events [AEs]

    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.

    Time frame: 0-168 days

  2. Efficacy: A Significant Thermogenesis at the Injected Site.

    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.

    Time frame: 28-168 days

Secondary outcomes

  1. Duration of the Thermogenic Effect From Day 28.

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

    Time frame: 28-168 days

  2. Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.

    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.

    Time frame: 28-168 days

  3. Changes in Fasting Blood Glucose From Baseline.

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

    Time frame: 56 days

  4. Changes in Blood Lipid Profile From Baseline.

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

    Time frame: 56 days

  5. Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.

    Averaged Cmax values by cohort.

    Time frame: 1-2 days

  6. Changes in Body Weight

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

    Time frame: 56 days

  7. Changes in Waist to Hip Ratio [WHR]

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

    Time frame: 56 days

  8. Elucidation of the Histological Changes Account for the Thermogenic Effect.

    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.

    Time frame: 56 days

  9. Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.

    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.

    Time frame: 28 days

  10. Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.

    Averaged Tmax values by cohort.

    Time frame: 0.5, 1,2,3,4,5,6,8,12,16,24,30 hours

07

Results

Posted Aug 21, 2019

Participant flow

Participant flow — Overall Study
MilestoneRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Started66669
Completed66667
Not completed00002
Withdrew: Lost to follow-up00002

Outcome measures

PrimarySafety: The Incidence of Treatment-related Adverse Events [AEs]

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.

Time frame:
0-168 days
Reported as:
Number · participants
Safety: The Incidence of Treatment-related Adverse Events [AEs]
participantsRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Serious Adverse Events00000
Other Adverse Events66669
Cardiac disorder ventricular extrasystoles00001
Ear and labyrinth disorders - Ear pain00001
Ear and labyrinth disorders Ear swelling00001
Ear and labyrinth disorders - Hypoacusis00001
Ear and labyrinth disorders otorrhoea00002
Aministration site condition - energy uncreased10000
Aministration site condition - Fatifue10000
Administration site condition - feeling hot00100
Administration site condition - bruising11123
Administration site condition - discolourization00010
Administration site condition - Erythema66458
Administration site condition - hemorrhage00100
Administration site condition - injection mass00010
Administration site condition - nodule00010
Administration site condition- Edema64645
Administration site condition - pain65553
Administration site condition- pruritus20020
Administration site condition - rash10000
Administration site condition - warmth20000
Administration site condition medical device reac00100
general condition non cardiac chest pain01000
Injury and procedure complications - skin abrasion01000
Investigations - Electrodiagram QT prolonged00001
Muscoloskeletal and connective tissue - myalgia00100
Muscoloskeletal and connective tissue - pain extre00001
Nervou system disorders- Dizziness00100
Nervou system disorders - Headache21201
Respeiratory, thoracic - oropharyngea pain00100
Respeiratory, thoracic - Respiratory tracongestion01000
Respeiratory, thoracic - Rhinorrhoea10100
skin and subcutaneous tissue disorders - erythema00300
skin and subcutaneous tissue disorders hyperhidros00100
skin and subcutaneous tissue disorders - pruritus00010
PrimaryEfficacy: A Significant Thermogenesis at the Injected Site.

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.

Time frame:
28-168 days
Reported as:
Count of participants · Participants
Efficacy: A Significant Thermogenesis at the Injected Site.
ParticipantsRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Day 2855361
Day 5613360
Day 84NANANA40
Day 112NANANA50
Day 140NANANA40
Day 168NANANA30
SecondaryDuration of the Thermogenic Effect From Day 28.

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

Time frame:
28-168 days
Reported as:
Mean · days
Duration of the Thermogenic Effect From Day 28.
daysRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Duration of the Thermogenic Effect From Day 28.5.6 ± 12.516.8 ± 15.35.6 ± 12.5107.3 ± 44.90 ± 0
SecondaryLocal Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.

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.

Time frame:
28-168 days
Reported as:
Mean · percentage of SFM reduction
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
percentage of SFM reductionRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Day 28-0.62 ± 5.17-9.15 ± 10.55-9.1 ± 4.27-14.68 ± 8.162.94 ± 10.08
Day 56NA ± NA-8.56 ± 8.85-10.52 ± 8.42-18.10 ± 10.933.61 ± 3.48
Day 84NA ± NANA ± NANA ± NA-12.75 ± 9.83-6.57 ± 9.78
Day 112NA ± NANA ± NANA ± NA-16.10 ± 13.81-8.2 ± 11.54
Day 140NA ± NANA ± NANA ± NA-12.46 ± 11.26-2.9 ± 0.45
Day 168NA ± NANA ± NANA ± NA-14.32 ± 10.94-2.54 ± 8.57
Statistical analysis
  • RZL-012 Cohort 1 vs Placebo · Kruskal-Wallis · p = >0.05
  • RZL-012 Cohort 2 vs Placebo · Kruskal-Wallis · p = <0.05
  • RZL-012 Cohort 3 vs Placebo · Kruskal-Wallis · p = <0.05
  • RZL-012 Cohort 4 vs Placebo · Kruskal-Wallis · p = <0.05
SecondaryChanges in Fasting Blood Glucose From Baseline.

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

Time frame:
56 days
Reported as:
Mean · mg/dL
Changes in Fasting Blood Glucose From Baseline.
mg/dLRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Day -186.7 ± 4.291.3 ± 5.1691.7 ± 7.4790.8 ± 7.1793.2 ± 3.93
Day 5693 ± 3.2292.8 ± 11.893.3 ± 7.5893.7 ± 5.394.6 ± 6.6
Statistical analysis
  • RZL-012 Cohort 1 vs Placebo · t-test, 2 sided · p = >0.05
  • RZL-012 Cohort 2 vs Placebo · t-test, 2 sided · p = >0.05
  • RZL-012 Cohort 3 vs Placebo · t-test, 2 sided · p = >0.05
  • RZL-012 Cohort 4 vs Placebo · t-test, 2 sided · p = >0.05
SecondaryChanges in Blood Lipid Profile From Baseline.

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

Time frame:
56 days
Reported as:
Mean · mg/dL
Changes in Blood Lipid Profile From Baseline.
mg/dLRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Cholesterol Day -1188 ± 32.8199 ± 11196 ± 41.4170.8 ± 23186.7 ± 19.8
Cholesterol Day 56184 ± 39.8205 ± 29.7201.7 ± 46.1176 ± 28.6182.4 ± 19.3
HDL Day -143.5 ± 7.2344.33 ± 11.141.5 ± 644 ± 6.8742.44 ± 5.6
HDL Day 5640 ± 9.4450.8 ± 14.241.5 ± 9.945.3 ± 5.0541.14 ± 7
LDL Day -1129 ± 33.5126.5 ± 13.3134 ± 33105.5 ± 15116 ± 10.3
LDL Day 56120 ± 31.3132 ± 23.9134.7 ± 37128 ± 0103 ± 14.8
Triglycerides Day -1107.3 ± 42.3131 ± 77112.5 ± 58.9121.7 ± 39.3155.8 ± 98
Triglycerides Day 56118 ± 85.4136 ± 61.1193.5 ± 16.7128.33 ± 55.4234 ± 220
SecondaryPharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.

Averaged Cmax values by cohort.

Time frame:
1-2 days
Reported as:
Mean · ng/mL
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.
ng/mLRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.84.15 ± 16.27181.89 ± 49.86241 ± 72.09344 ± 73.7
SecondaryChanges in Body Weight

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

Time frame:
56 days
Reported as:
Mean · Kg
Changes in Body Weight
KgRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Weight Day -1103.3 ± 11.195.4 ± 6.9101.3 ± 20.396.1 ± 12.699.1 ± 8.1
Weight Day 56104.4 ± 12.596.1 ± 7.8103.4 ± 22.496 ± 12.3101.2 ± 9.7
SecondaryChanges in Waist to Hip Ratio [WHR]

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

Time frame:
56 days
Reported as:
Mean · ratio
Changes in Waist to Hip Ratio [WHR]
ratioRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Waist to hip ratio Day -11 ± 0.11 ± 01 ± 0.11 ± 01 ± 0.1
Waist to hip ratio Day 561 ± 01 ± 01 ± 01 ± 01 ± 0.1
SecondaryElucidation of the Histological Changes Account for the Thermogenic Effect.

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.

Time frame:
56 days
Reported as:
Count of participants · Participants
Elucidation of the Histological Changes Account for the Thermogenic Effect.
ParticipantsRZL-012 Cohort 3Placebo
Elucidation of the Histological Changes Account for the Thermogenic Effect.21
SecondaryChange From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.

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.

Time frame:
28 days
Reported as:
Mean · mg/dL
Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.
mg/dLRZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
CRP Day -1 (mg/dL)0.2 ± 0.130.6 ± 1.080.5 ± 00.2 ± 0.1
CRP Day 28 (mg/dL)0.27 ± 0.310.2 ± 0.120.43 ± 0.150.2 ± 0.1
Statistical analysis
  • RZL-012 Cohort 4 vs Placebo · t-test, 2 sided · p = >0.05
SecondaryPharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.

Averaged Tmax values by cohort.

Time frame:
0.5, 1,2,3,4,5,6,8,12,16,24,30 hours
Reported as:
Mean · Hour
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.
HourRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.1.83 ± 0.411.83 ± 0.411.83 ± 0.412 ± 0

Adverse events

Collected over 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.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RZL-012 Cohort 10/6 (0%)0/6 (0%)6/6 (100%)
RZL-012 Cohort 20/6 (0%)0/6 (0%)6/6 (100%)
RZL-012 Cohort 30/6 (0%)0/6 (0%)6/6 (100%)
RZL-012 Cohort 40/6 (0%)0/6 (0%)6/6 (100%)
Placebo0/9 (0%)0/9 (0%)9/9 (100%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventRZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4Placebo
Injection site ErythemaGeneral disorders6/66/64/65/68/9
Injection site EdemaGeneral disorders6/64/66/64/65/9
Injection site painGeneral disorders6/65/65/65/63/9
ErythemaSkin and subcutaneous tissue disorders0/60/63/60/60/9
Injection site bruisingGeneral disorders1/61/61/62/63/9
Injection site pruritusGeneral disorders2/60/60/62/60/9
Injection site warmthGeneral disorders2/60/60/60/60/9
HeadacheNervous system disorders2/61/62/60/61/9
Energy increasedGeneral disorders1/60/60/60/60/9
fatigueGeneral disorders1/60/60/60/60/9

Baseline characteristics

20-60 years old, overweight and obese by BMI definition (27.5 \< BMI ≤ 34.9), adult males.

Age, Categorical
Age, Categorical(Participants)RZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4PlaceboTotal
<=18 years000000
Between 18 and 65 years6666933
>=65 years000000
Age, Continuous
Age, Continuous(years)RZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4PlaceboTotal
Mean31.7 ± 2.144.5 ± 12.140 ± 11.841.7 ± 13.239.2 ± 10.339.4 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)RZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4PlaceboTotal
Female000000
Male6666933
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4PlaceboTotal
Hispanic or Latino010012
Not Hispanic or Latino6566831
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)RZL-012 Cohort 1RZL-012 Cohort 2RZL-012 Cohort 3RZL-012 Cohort 4PlaceboTotal
United States6666933
08

Study locations

1 site
  • Spaulding Clinical
    West Bend, Wisconsin 53095, United States
09

References and documents

Study documents

  • Study protocol · Mar 4, 2018
  • Statistical analysis plan · Nov 14, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03171415
Lead sponsor
Raziel Therapeutics Ltd.
Collaborators
Spaulding Clinical Research LLC
Responsible party
Sponsor
First posted
May 31, 2017
Start date
Jul 25, 2017
Primary completion
Dec 28, 2018
Completion
Dec 28, 2018
Results posted
Aug 21, 2019
Last update
Aug 21, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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