ObesityPhase 2NCT03364335
The Effect Of NS-0200 and NS-0300 Versus Placebo on Weight In Obesity
A Phase 2 study testing Leu Sil 1.0mg, Leu Sil 4.0mg and Leu Met Sil 1.0mg in people with Obesity, run by NuSirt Biopharma at 15 sites in United States.
Trial summary
This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Leu Sil 1.0mg, Leu Sil 4.0mg and Leu Met Sil 1.0mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 Jan 2018to 17 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤65 at study entry.
- Is male, or female and, if female, meets all of the following criteria:
- Not breastfeeding
- Post-menopausal or negative serum pregnancy test result (human chorionic gonadotropin, beta subunit [β-hCG]) at Screening/Visit 1 (Day-7/Week-1) (not required for hysterectomized females)
- If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study
- Stable body weight (±5%) and health over the last 3 months.
Show all 11Show fewer
- Has a BMI between 30 kg/m2 and 45 kg/m2
- Stable diet within the last three months
- Subjects on antidepressants, excluding those listed in the exclusion criteria, must have been on a stable dose regiment for at least 3 months prior to study enrollment and maintain stable dose during the study
- Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal, not clinically significant or with abnormalities consistent with obesity
- Is able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.
Who cannot join
- Diagnosis of diabetes or on a diabetes medication
- HbA1c ≥6.5% at Screening/Visit 1 (Day-7/Week-1)
- Severe renal impairment (eGFR < 45 mg/mL/1.73 m2) and/or patients with acute or chronic metabolic acidosis. Acidosis is defined as >25mmol/L computed without K.
- Normal is 8- 16, but acidosis is >25
- Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study:
- Use of any anti-diabetes medication including metformin and any combination drug that contains metformin
Show all 47Show fewer
- Sildenafil
- Tadalafil
- Vardenafil
- OCT2/MATE inhibitors (e.g. cimetidine, quinidine, and pyrimethamine)
- Riociguat (guanylate cyclase stimulant)
- Alpha blockers
- Nitrates (e.g. oral nitrates, sublingual nitroglycerine and nitroglycerine patches)
- Potent CYP3A4 inhibitors (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir)
- All antihypertensive medications
- Medications associated with weight changes
- Drugs approved for the treatment of obesity
- Cypropheptadine or medroxyprogesterone
- Atypical anti-psychotic drugs
- Tricyclic antidepressants
- Lithium, MAO's, glucocorticoids
- SSRI's or SNRI's
- Antiepileptic drugs
- Systemic corticosteroids
- Stimulants e.g. amphetamines
- Any dietary supplement that is labeled for weight management or maintenance of healthy weight
- Diagnosis or evidence of eating disorders
- ≥ 5% weight change in the last 3 months
- Subjects who have had bariatric surgery
- An infection requiring antibiotic treatment within the last 30 days
- Any chronic inflammatory disease, e.g. inflammatory bowel disease rheumatoid arthritis, vasculitis, systemic lupus erythematosus
- Diseases interfering with metabolism (including metabolism of branched chain amino acids) and/or ingestive behavior (myxedema, Cushing's disease, diabetes, schizophrenia, major psychoses, maple syrup urine disease, unmanaged depression etc.)
- History of alcohol abuse (defined ≥ 21 drinks per week for males and > 14 drinks per week for females), within the past 3 months or failure on urinary drug screen
- History of substance abuse (including alcohol abuse as defined above) in the past 12 months or a positive screen for drugs (opioids without a prescription), including marijuana, of abuse or alcohol at screening.
- Has received any investigational drug within 3 months of Screening.
- Has donated blood within 3 months before Screening or is planning to donate blood during the study (due to HbA1c reading at screening)
- Other medical conditions that may diminish life expectancy to <2 years, including known cancers
- Have been diagnosed with metastatic carcinomas in the last 5 years
- Has known allergies or hypersensitivity to metformin, sildenafil or leucine
- Have suffered myocardial infarction, stroke, arrhythmia in the last 6 months
- Resting hypotension (BP <90/50 mmHg) or severe hypertension (BP >170/110 mmHg) If both or one of the parameters for diastolic or systolic BP is meet
- Cardiac failure or coronary artery disease causing unstable angina
- History or evidence at screening of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure
- At risk for priapism due to anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie's disease) or other conditions that predispose to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia)
- Clinical evidence of hepatic impairment and/or ALT/AST >5X ULN
- Is an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or NuSirt Biopharma.
- Is employed by NuSirt Biopharma (defined as an employee, temporary contract worker, or designee responsible for the conduct of the study).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Medical Research South
Charleston, South Carolina, 29407
Synexus
Chicago, Illinois, 60602
Premier
Clarksville, Tennessee, 37040
Rapid Medical Research
Cleveland, Ohio, 44122
Synexus
Dallas, Texas, 75234
ACR
Jordan, Utah, 84088
AMR
Las Vegas, Nevada, 89119
ACR
Meridian, Idaho, 83642
Clinical Trials Management
Metairie, Louisiana, 70006
AMR
Mobile, Alabama, 36608
Catalina Research Institute
Montclair, California, 91763
Northern California Research
Sacramento, California, 95821
Synexus
San Antonio, Texas, 78229
Synexus
St Louis, Missouri, 63141
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Effects of Two Fixed-dose Leucine-sildenafil Combinations (NS-0300) or Two Fixed-dose Leucine-sildenafil-metformin Combinations (NS-0200) Versus Placebo on Body Weight in Obesity
This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).
Read the detailed description
This is a randomized, 24-week, placebo-controlled, double-blind study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of five study arms.
The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24) receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives will also assess changes in absolute body weight, percentage of patients with ≥5% body weight loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200 and NS-0300.
Patients will have one screening visits which will determine their eligibility based on lab tests. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 24 weeks. Patients will return to the clinic each month for lab tests, and routine examinations.
- Conditions
- Obesity
- Being tested
- Leu Sil 1.0mg, Leu Sil 4.0mg, Leu Met Sil 1.0mg, Leu Met Sil 4.0mg, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leu Sil 1.0mgDrug
Also called NS-0300-1.0
Leu 1100 mg + 1mg Sil BID
Leu Sil 4.0mgDrug
Also called NS-0300-4.0
Leu 1100 mg + 4mg Sil BID
Leu Met Sil 1.0mgDrug
Also called NS-0200-1.0
Leu 1100 mg + Met 500mg + 1mg Sil BID
Leu Met Sil 4.0mgDrug
Also called NS-0200-4.0
Leu 1100 mg + Met 500mg + 4mg Sil BID
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Each dose of placebo will consist of three tablets, identical in appearance to those used in the two active treatment arms, containing 93.5% Microcrystalline cellulose PH 102, 5.0% Crospovidone XL 10, 1.0% Silica gel (Syloid 244), 0.5% Magnesium stearate I MF3V for the leucine matched placebo and 99.5% Avicel PH200 , 0.5% magnesium stearate (w/w) and Opadry II White coating 3% weight gain for the sildenafil matched placebo. Receives: Drug: Placebo |
| Leu Sil 1.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil Receives: Drug: Leu Sil 1.0mg; Drug: Leu Sil 4.0mg |
| Leu Sil 4.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil Receives: Drug: Leu Sil 1.0mg; Drug: Leu Met Sil 1.0mg |
| Leu Met Sil 1.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil Receives: Drug: Leu Sil 1.0mg; Drug: Leu Sil 4.0mg; Drug: Leu Met Sil 4.0mg |
| Leu Met Sil 4.0mg | Experimental | 3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil Receives: Drug: Leu Sil 1.0mg; Drug: Leu Met Sil 1.0mg; Drug: Leu Met Sil 4.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Body Weight Change
The percentage body weight change from baseline to Day 168 was evaluated.
Measured: Baseline to Day 168
Secondary outcomes (12)
Change in Absolute Body Weight
The change in absolute body weight from baseline to day 168 was evaluated.
Measured: Baseline to Day 168
Change in Percentage of Patients With ≥5% Body Weight Loss
The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.
Measured: Baseline to Day 168
Change in Waist Circumference
The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.
Measured: Baseline to Day 168
Change in Total Cholesterol
Changes in total cholesterol was examined by standard blood chemistry.
Measured: Baseline to Day 168
Change in HDL Cholesterol
Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.
Measured: Baseline, Day 168
Change in LDL Cholesterol
Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.
Measured: Baseline, 168 days
Change in Triglycerides
The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.
Measured: Baseline, Day 168
Change in Plasma Glucose
Change in plasma glucose was examined through standard fasting blood chemistry.
Measured: Baseline to Day 168
Change in Hemoglobin A1c (HbA1c)
Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.
Measured: Baseline, Day 168
Change in Diastolic Blood Pressure
Diastolic blood pressure was measured by standard blood pressure monitor.
Measured: Baseline to Day 168
Change in Systolic Blood Pressure
Change in Systolic blood pressure was assessed in patients from baseline to Day 168
Measured: Baseline, Day 168
Change in Inflammatory Markers
hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.
Measured: Baseline to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start8 Jan 2018
- Primary completion6 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuSirt Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Zemel, PhD, Study chair, NuSirt Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364335
- Sponsor's protocol ID
- NS-WM-01
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2017
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Effects of Two Fixed-dose Leucine-sildenafil Combinations (NS-0300) or Two Fixed-dose Leucine-sildenafil-metformin Combinations (NS-0200) Versus Placebo on Body Weight in Obesity
- ClinicalTrials.gov ID
- NCT03364335
- Acronym / sponsor ID
- NS-WM-01
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- NuSirt BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 27 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 24-week study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24).
Detailed description
This is a randomized, 24-week, placebo-controlled, double-blind study to evaluate the effects of two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Subjects meeting all the inclusion criteria and no exclusion criteria will be randomized to one of five study arms.
The primary objective of this study is to evaluate the percentage change in body weight in subjects from Baseline/Visit 2 (Day 1) to Study Termination/Visit 8 (Day 168/Week 24) receiving two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin compared to placebo. Secondary objectives will also assess changes in absolute body weight, percentage of patients with ≥5% body weight loss, change in waist circumference, change in HbA1c, change in fasting glucose, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, change in blood pressure and changes in in C-reactive protein. In addition this study will evaluate the safety and tolerability of NS-0200 and NS-0300.
Patients will have one screening visits which will determine their eligibility based on lab tests. Once qualified, patients will be randomly assigned to either one of the treatment groups or the placebo control group and monitored for a total of 24 weeks. Patients will return to the clinic each month for lab tests, and routine examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboEach dose of placebo will consist of three tablets, identical in appearance to those used in the two active treatment arms, containing 93.5% Microcrystalline cellulose PH 102, 5.0% Crospovidone XL 10, 1.0% Silica gel (Syloid 244), 0.5% Magnesium stearate I MF3V for the leucine matched placebo and 99.5% Avicel PH200 , 0.5% magnesium stearate (w/w) and Opadry II White coating 3% weight gain for the sildenafil matched placebo. |
| Leu Sil 1.0mg | Experimental | Drug: Leu Sil 1.0mg, Drug: Leu Sil 4.0mg3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 1.0 mg of sildenafil |
| Leu Sil 4.0mg | Experimental | Drug: Leu Sil 1.0mg, Drug: Leu Met Sil 1.0mg3 capsules BID consisting of 2 capsules containing 550 mg L-leucine each and 1 capsule containing 4.0 mg of sildenafil |
| Leu Met Sil 1.0mg | Experimental | Drug: Leu Sil 1.0mg, Drug: Leu Sil 4.0mg, Drug: Leu Met Sil 4.0mg3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 1.0 mg of sildenafil |
| Leu Met Sil 4.0mg | Experimental | Drug: Leu Sil 1.0mg, Drug: Leu Met Sil 1.0mg, Drug: Leu Met Sil 4.0mg3 capsules BID consisting of 2 capsules containing 550 mg L-leucine and 250 mg metformin and 1 capsule containing 4.0 mg of sildenafil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 and ≤65 at study entry.
- Is male, or female and, if female, meets all of the following criteria:
- Stable body weight (±5%) and health over the last 3 months.
- Has a BMI between 30 kg/m2 and 45 kg/m2
- Stable diet within the last three months
Key exclusion criteria (47 listed)
- Diagnosis of diabetes or on a diabetes medication
- HbA1c ≥6.5% at Screening/Visit 1 (Day-7/Week-1)
- Severe renal impairment (eGFR < 45 mg/mL/1.73 m2) and/or patients with acute or chronic metabolic acidosis. Acidosis is defined as >25mmol/L computed without K.
- Normal is 8- 16, but acidosis is >25
- Use of any of the following medications in the eight weeks prior to entering screening for study participation and during the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leu Sil 1.0mgAlso: NS-0300-1.0Leu 1100 mg + 1mg Sil BID | Drug | Leu Met Sil 1.0mg, Leu Met Sil 4.0mg, Leu Sil 1.0mg, Leu Sil 4.0mg |
| Leu Sil 4.0mgAlso: NS-0300-4.0Leu 1100 mg + 4mg Sil BID | Drug | Leu Met Sil 1.0mg, Leu Sil 1.0mg |
| Leu Met Sil 1.0mgAlso: NS-0200-1.0Leu 1100 mg + Met 500mg + 1mg Sil BID | Drug | Leu Met Sil 4.0mg, Leu Sil 4.0mg |
| Leu Met Sil 4.0mgAlso: NS-0200-4.0Leu 1100 mg + Met 500mg + 4mg Sil BID | Drug | Leu Met Sil 1.0mg, Leu Met Sil 4.0mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage Body Weight Change
Time frame: Baseline to Day 168
The percentage body weight change from baseline to Day 168 was evaluated.
12 secondary outcomes
Change in Absolute Body Weight
Time frame: Baseline to Day 168
Change in Percentage of Patients With ≥5% Body Weight Loss
Time frame: Baseline to Day 168
Change in Waist Circumference
Time frame: Baseline to Day 168
Change in Total Cholesterol
Time frame: Baseline to Day 168
Change in HDL Cholesterol
Time frame: Baseline, Day 168
Change in LDL Cholesterol
Time frame: Baseline, 168 days
Change in Triglycerides
Time frame: Baseline, Day 168
Change in Plasma Glucose
Time frame: Baseline to Day 168
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Day 168
Change in Diastolic Blood Pressure
Time frame: Baseline to Day 168
Change in Systolic Blood Pressure
Time frame: Baseline, Day 168
Change in Inflammatory Markers
Time frame: Baseline to Day 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zemel, PhD study chair
NuSirt Biopharma
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leu Sil 1.0mg, Leu Sil 4.0mg and Leu Met Sil 1.0mg in people with Obesity, run by NuSirt Biopharma at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Body Weight Change (time frame: Baseline to Day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.