ObesityNCT02388568
Lifestyle Modification and Lorcaserin for Weight Loss Maintenance
A study testing Lorcaserin in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss achieved during a prior 14-week dietary run-in. 14-week run-in. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lorcaserin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2017
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have lost ≥ 5% of initial weight in the group lifestyle modification program (during the 14-week diet run-in period).
- Participants must have a BMI ≥ 30 and ≤ 55 kg/m² or have a BMI ≥ 27 kg/m² with a obesity-related co-morbid condition
- Age ≥ 21 years and ≤ 65
- Eligible female patients will be:
- non-pregnant, evidenced by a negative urine dipstick pregnancy test
- non-lactating
- surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study
- Participants must have a primary care provider (PCP) who is responsible for providing routine care and have a reliable telephone service with which to participate in conference calls
Who cannot join
- Pregnant or nursing (or plans to become pregnant in the next 18 months)
- Current major depressive episode, active suicidal ideation, or history of suicide attempts
- Use in the past 14 days of monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclics, lithium, triptans, antipsychotics, cabergoline, linezolid, tramadol, dextromethorphan, tryptophan, bupropion, St. John's Wort, or medicines to treat erectile dysfunction
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg, or diastolic blood pressure ≥ 100 mm Hg)
- Type 1 diabetes or type 2 diabetes
- A fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6.5
Show all 15Show fewer
- Recent history of cardiovascular disease (e.g., myocardial infarction or stroke within the past 6 months), congestive heart failure, or heart block greater than first degree
- Clinically significant hepatic or renal disease
- Thyroid disease not controlled
- History of malignancy (except for non-melanoma skin cancer)
- Use of medications known to induce significant weight loss/gain, including chronic use of oral steroids
- Psychiatric hospitalization within the past 6 months
- Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)
- Loss of ≥ 10 lb of body weight within the past 3 months
- History of (or plans for) bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of Lifestyle Modification and Lorcaserin for Weight Loss Maintenance
The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss achieved during a prior 14-week dietary run-in.
14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight in the 14-week dietary run-in. This loss will be achieved with the provision of weekly, group lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are expected to achieve the 5% criterion loss during the 14-week run-in.
Read more
A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30 and ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in the 4-month run-in period. Prior to enrollment, all participants will have a history, physical exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly group sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check their health and blood tests will be repeated. The investigators anticipate that 136 (75%) participants will lose 5% or more of initial weight and qualify for randomization. Participants who do not lose 5% will be provided a list of weight loss resources (e.g., other programs) to facilitate their continued weight management.
12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or more of initial weight in the run-in period will be randomly assigned, in double-blind fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational Drug Service at the Hospital of the University of Pennsylvania. Prior to randomization, all participants will complete a second brief history and physical examination, as well as an EKG and blood tests. Medication will be dispensed at the randomization visit and at brief medical visits that follow. Over the 1 year, all participants will participate in 16 group lifestyle modification classes designed for weight loss maintenance, approximately half of which will be delivered by group conference call.
Primary outcome measure. The primary endpoint is change in body weight (in kg), as measured from randomization to month 12. The co-primary end-point is the percentage of participants in the two groups that, at month 12, maintained the ≥5% reduction in body weight achieved during the 14-week dietary run-in period. Secondary efficacy endpoints include changes in CVD risk factors, glycemic control, and quality of life, as measured from randomization to month 12. Exploratory endpoints include changes in these CVD and related outcomes, as measured at the start of the 14-week run-in period to month 12. The investigators also will examine the percentage of participants in the two groups who at month 12 achieved losses of ≥5%, ≥10%, and ≥15% of initial weight, as measured from the start of the run-in period.
Safety endpoints will include physical examination, electrocardiogram, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).
Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization ratio, assumes a 20% drop-out rate (at month 12) and was estimated to be adequate to evaluate the primary endpoint with power ≥90% (P=0.05, two-sided test). The investigators predict a difference in weight change between the two groups (from randomization to month 12) of 4 kg (SD=3.5). Pre-specified data analysis will be performed on the full analysis set, comprising all randomized individuals exposed to trial drug with at least one post-randomization weight assessment.
- Conditions
- Obesity
- Being tested
- Lorcaserin, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorcaserinDrug
Lorcaserin plus Lifestyle Modification
PlaceboDrug
Placebo plus Lifestyle Modification
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin plus Lifestyle Modification | Active comparator | Not described Receives: Drug: Lorcaserin |
| Placebo plus Lifestyle Modification | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight (kg)
This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.
Measured: 52 weeks post-randomization
Proportion Maintaining >= 5% Loss of Initial Weight
This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.
Measured: 52 weeks post-randomization
Secondary outcomes (4)
Body Weight (% Change)
The % change in body weight from randomization to week 52.
Measured: 52 weeks post-randomization
Proportion Maintaining >= 10% Loss of Initial Weight
This is the number of participants who maintained >=10% loss of initial weight in the randomization to week 52 trial period.
Measured: 52 weeks post-randomization
Body Weight
This is the change in weight from baseline (screening visit) to the final week 52 medical assessment visit.
Measured: -14 week (start of LCD program) to week 52
Body Weight (% Change)
This is the change in weight from the baseline (screening visit) to the final week 52 medical assessment visit.
Measured: -14 week (start of LCD program) to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas A Wadden, Ph.D., Principal investigator, University of PennsylvaniaRobert I Berkowitz, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388568
- Sponsor's protocol ID
- Eisai-819111
- Status last verified
- May 2018
- First submitted
- 29 Jan 2015
- Last updated
- 11 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pearl RL, Wadden TA, Chao AM, Walsh O, Alamuddin N, Berkowitz RI, Tronieri JS. Weight Bias Internalization and Long-Term Weight Loss in Patients With Obesity. Ann Behav Med. 2019 Jul 17;53(8):782-787. doi: 10.1093/abm/kay084.
PubMed 30304382Pearl RL, Wadden TA, Allison KC, Chao AM, Alamuddin N, Berkowitz RI, Walsh O, Tronieri JS. Causal Attributions for Obesity Among Patients Seeking Surgical Versus Behavioral/Pharmacological Weight Loss Treatment. Obes Surg. 2018 Nov;28(11):3724-3728. doi: 10.1007/s11695-018-3490-7.
PubMed 30191502Pearl RL, Wadden TA, Tronieri JS, Berkowitz RI, Chao AM, Alamuddin N, Leonard SM, Carvajal R, Bakizada ZM, Pinkasavage E, Gruber KA, Walsh OA, Alfaris N. Short- and Long-Term Changes in Health-Related Quality of Life with Weight Loss: Results from a Randomized Controlled Trial. Obesity (Silver Spring). 2018 Jun;26(6):985-991. doi: 10.1002/oby.22187. Epub 2018 Apr 20.
PubMed 29676530Shaw Tronieri J, Wadden TA, Berkowitz RI, Chao AM, Pearl RL, Alamuddin N, Leonard SM, Carvajal R, Bakizada ZM, Pinkasavage E, Gruber KA, Walsh OA, Alfaris N. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss Achieved with a Low-Calorie Diet. Obesity (Silver Spring). 2018 Feb;26(2):299-309. doi: 10.1002/oby.22081. Epub 2017 Dec 29.
PubMed 29288545Tronieri JS, Alfaris N, Chao AM, Pearl RL, Alamuddin N, Bakizada ZM, Berkowitz RI, Wadden TA. Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial. Contemp Clin Trials. 2017 Aug;59:105-112. doi: 10.1016/j.cct.2017.06.004. Epub 2017 Jun 16.
PubMed 28600158Pearl RL, Wadden TA, Hopkins CM, Shaw JA, Hayes MR, Bakizada ZM, Alfaris N, Chao AM, Pinkasavage E, Berkowitz RI, Alamuddin N. Association between weight bias internalization and metabolic syndrome among treatment-seeking individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):317-322. doi: 10.1002/oby.21716.
PubMed 28124502
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Lifestyle Modification and Lorcaserin for Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT02388568
- Acronym / sponsor ID
- Eisai-819111
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss achieved during a prior 14-week dietary run-in.
14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight in the 14-week dietary run-in. This loss will be achieved with the provision of weekly, group lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are expected to achieve the 5% criterion loss during the 14-week run-in.
A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30 and ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in the 4-month run-in period. Prior to enrollment, all participants will have a history, physical exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly group sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check their health and blood tests will be repeated. The investigators anticipate that 136 (75%) participants will lose 5% or more of initial weight and qualify for randomization. Participants who do not lose 5% will be provided a list of weight loss resources (e.g., other programs) to facilitate their continued weight management.
12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or more of initial weight in the run-in period will be randomly assigned, in double-blind fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational Drug Service at the Hospital of the University of Pennsylvania. Prior to randomization, all participants will complete a second brief history and physical examination, as well as an EKG and blood tests. Medication will be dispensed at the randomization visit and at brief medical visits that follow. Over the 1 year, all participants will participate in 16 group lifestyle modification classes designed for weight loss maintenance, approximately half of which will be delivered by group conference call.
Primary outcome measure. The primary endpoint is change in body weight (in kg), as measured from randomization to month 12. The co-primary end-point is the percentage of participants in the two groups that, at month 12, maintained the ≥5% reduction in body weight achieved during the 14-week dietary run-in period. Secondary efficacy endpoints include changes in CVD risk factors, glycemic control, and quality of life, as measured from randomization to month 12. Exploratory endpoints include changes in these CVD and related outcomes, as measured at the start of the 14-week run-in period to month 12. The investigators also will examine the percentage of participants in the two groups who at month 12 achieved losses of ≥5%, ≥10%, and ≥15% of initial weight, as measured from the start of the run-in period.
Safety endpoints will include physical examination, electrocardiogram, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9).
Statistical Analysis. The planned sample size of 136 participants, with a 1:1 randomization ratio, assumes a 20% drop-out rate (at month 12) and was estimated to be adequate to evaluate the primary endpoint with power ≥90% (P=0.05, two-sided test). The investigators predict a difference in weight change between the two groups (from randomization to month 12) of 4 kg (SD=3.5). Pre-specified data analysis will be performed on the full analysis set, comprising all randomized individuals exposed to trial drug with at least one post-randomization weight assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin plus Lifestyle Modification | Active comparator | Drug: Lorcaserin |
| Placebo plus Lifestyle Modification | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must have lost ≥ 5% of initial weight in the group lifestyle modification program (during the 14-week diet run-in period).
- Participants must have a BMI ≥ 30 and ≤ 55 kg/m² or have a BMI ≥ 27 kg/m² with a obesity-related co-morbid condition
- Age ≥ 21 years and ≤ 65
- Eligible female patients will be:
- Participants must have a primary care provider (PCP) who is responsible for providing routine care and have a reliable telephone service with which to participate in conference calls
Key exclusion criteria (15 listed)
- Pregnant or nursing (or plans to become pregnant in the next 18 months)
- Current major depressive episode, active suicidal ideation, or history of suicide attempts
- Use in the past 14 days of monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), tricyclics, lithium, triptans, antipsychotics, cabergoline, linezolid, tramadol, dextromethorphan, tryptophan, bupropion, St. John's Wort, or medicines to treat erectile dysfunction
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg, or diastolic blood pressure ≥ 100 mm Hg)
- Type 1 diabetes or type 2 diabetes
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 |
|---|---|---|
| LorcaserinLorcaserin plus Lifestyle Modification | Drug | Lorcaserin plus Lifestyle Modification |
| PlaceboPlacebo plus Lifestyle Modification | Drug | Placebo plus Lifestyle Modification |
Primary outcome
Change in Weight (kg)
Time frame: 52 weeks post-randomization
This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.
Proportion Maintaining >= 5% Loss of Initial Weight
Time frame: 52 weeks post-randomization
This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.
4 secondary outcomes
Body Weight (% Change)
Time frame: 52 weeks post-randomization
Proportion Maintaining >= 10% Loss of Initial Weight
Time frame: 52 weeks post-randomization
Body Weight
Time frame: -14 week (start of LCD program) to week 52
Body Weight (% Change)
Time frame: -14 week (start of LCD program) to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30304382Pearl RL, Wadden TA, Chao AM, Walsh O, Alamuddin N, Berkowitz RI, Tronieri JS. Weight Bias Internalization and Long-Term Weight Loss in Patients With Obesity. Ann Behav Med. 2019 Jul 17;53(8):782-787. doi: 10.1093/abm/kay084.
- Derived from this study: PubMed 30191502Pearl RL, Wadden TA, Allison KC, Chao AM, Alamuddin N, Berkowitz RI, Walsh O, Tronieri JS. Causal Attributions for Obesity Among Patients Seeking Surgical Versus Behavioral/Pharmacological Weight Loss Treatment. Obes Surg. 2018 Nov;28(11):3724-3728. doi: 10.1007/s11695-018-3490-7.
- Derived from this study: PubMed 29676530Pearl RL, Wadden TA, Tronieri JS, Berkowitz RI, Chao AM, Alamuddin N, Leonard SM, Carvajal R, Bakizada ZM, Pinkasavage E, Gruber KA, Walsh OA, Alfaris N. Short- and Long-Term Changes in Health-Related Quality of Life with Weight Loss: Results from a Randomized Controlled Trial. Obesity (Silver Spring). 2018 Jun;26(6):985-991. doi: 10.1002/oby.22187. Epub 2018 Apr 20.
- Derived from this study: PubMed 29288545Shaw Tronieri J, Wadden TA, Berkowitz RI, Chao AM, Pearl RL, Alamuddin N, Leonard SM, Carvajal R, Bakizada ZM, Pinkasavage E, Gruber KA, Walsh OA, Alfaris N. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss Achieved with a Low-Calorie Diet. Obesity (Silver Spring). 2018 Feb;26(2):299-309. doi: 10.1002/oby.22081. Epub 2017 Dec 29.
- Derived from this study: PubMed 28600158Tronieri JS, Alfaris N, Chao AM, Pearl RL, Alamuddin N, Bakizada ZM, Berkowitz RI, Wadden TA. Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial. Contemp Clin Trials. 2017 Aug;59:105-112. doi: 10.1016/j.cct.2017.06.004. Epub 2017 Jun 16.
- Derived from this study: PubMed 28124502Pearl RL, Wadden TA, Hopkins CM, Shaw JA, Hayes MR, Bakizada ZM, Alfaris N, Chao AM, Pinkasavage E, Berkowitz RI, Alamuddin N. Association between weight bias internalization and metabolic syndrome among treatment-seeking individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):317-322. doi: 10.1002/oby.21716.
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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.
Thomas A Wadden, Ph.D. principal investigator
University of Pennsylvania
Robert I Berkowitz, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lorcaserin in people with Obesity, run by University of Pennsylvania at 1 site 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 8 inclusion and 15 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 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 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?
Change in Weight (kg) (time frame: 52 weeks post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388568, which also lists 6 linked publications.
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 11 Jun 2018.