A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

January 27, 2020 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo

This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Wien, Austria, 1010
        • Novartis Investigative Site
      • Wien, Austria, 1030
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Novartis Investigative Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • Novartis Investigative Site
      • Levis, Quebec, Canada, G6W 5M6
        • Novartis Investigative Site
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Novartis Investigative Site
      • Olomouc Lazce, Czechia, 77900
        • Novartis Investigative Site
      • Praha 1, Czechia, 116 94
        • Novartis Investigative Site
      • Praha 3, Czechia, 13000
        • Novartis Investigative Site
      • Slany, Czechia, 274 01
        • Novartis Investigative Site
    • Czech Republic
      • Praha 2, Czech Republic, Czechia, 128 08
        • Novartis Investigative Site
  • Hungary
      • Csongrad, Hungary, 6640
        • Novartis Investigative Site
      • Nyiregyhaza, Hungary, 4400
        • Novartis Investigative Site
      • Szentes, Hungary, 6600
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 85101
        • Novartis Investigative Site
      • Kosice, Slovakia, 040 01
        • Novartis Investigative Site
      • Sered, Slovakia, 92601
        • Novartis Investigative Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9DT
        • Novartis Investigative Site
      • Blackburn, United Kingdom, BB2 1AX
        • Novartis Investigative Site
      • Exeter, United Kingdom, EX2 5DW
        • Novartis Investigative Site
      • Rotherham, United Kingdom, S65 1DA
        • Novartis Investigative Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novartis Investigative Site
      • Jasper, Alabama, United States, 35501
        • Novartis Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • Novartis Investigative Site
      • Carmichael, California, United States, 95608
        • Novartis Investigative Site
      • Concord, California, United States, 94520
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90017
        • Novartis Investigative Site
      • Northridge, California, United States, 91325
        • Novartis Investigative Site
      • Roseville, California, United States, 95661
        • Novartis Investigative Site
      • San Ramon, California, United States, 94582
        • Novartis Investigative Site
      • Stockton, California, United States, 95204
        • Novartis Investigative Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80246
        • Novartis Investigative Site
      • Golden, Colorado, United States, 80401
        • Novartis Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Novartis Investigative Site
      • Fort Lauderdale, Florida, United States, 33312
        • Novartis Investigative Site
      • Port Charlotte, Florida, United States, 33952
        • Novartis Investigative Site
      • West Palm Beach, Florida, United States, 33401
        • Novartis Investigative Site
    • Georgia
      • Athens, Georgia, United States, 30606
        • Novartis Investigative Site
      • Augusta, Georgia, United States, 30909
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novartis Investigative Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Novartis Investigative Site
      • Springfield, Illinois, United States, 62711
        • Novartis Investigative Site
      • Wauconda, Illinois, United States, 60084
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Novartis Investigative Site
      • Evansville, Indiana, United States, 47714
        • Novartis Investigative Site
      • Indianapolis, Indiana, United States, 46260
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Novartis Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novartis Investigative Site
      • Covington, Louisiana, United States, 70433
        • Novartis Investigative Site
      • Hammond, Louisiana, United States, 70403
        • Novartis Investigative Site
      • Metairie, Louisiana, United States, 70006
        • Novartis Investigative Site
      • New Orleans, Louisiana, United States, 70115
        • Novartis Investigative Site
      • New Orleans, Louisiana, United States, 70119
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novartis Investigative Site
      • Beltsville, Maryland, United States, 20705
        • Novartis Investigative Site
      • Towson, Maryland, United States, 21204
        • Novartis Investigative Site
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Novartis Investigative Site
      • Saint Peters, Missouri, United States, 63303
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10455
        • Novartis Investigative Site
      • New York, New York, United States, 10016
        • Novartis Investigative Site
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Novartis Investigative Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Novartis Investigative Site
    • South Carolina
      • Moncks Corner, South Carolina, United States, 29464
        • Novartis Investigative Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Novartis Investigative Site
      • Summerville, South Carolina, United States, 29485
        • Novartis Investigative Site
    • Texas
      • Houston, Texas, United States, 77081
        • Novartis Investigative Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Novartis Investigative Site
      • Salt Lake City, Utah, United States, 84102
        • Novartis Investigative Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novartis Investigative Site
      • Richmond, Virginia, United States, 23294
        • Novartis Investigative Site
      • Richmond, Virginia, United States, 23235
        • Novartis Investigative Site
    • Washington
      • Renton, Washington, United States, 98057
        • Novartis Investigative Site
      • Tacoma, Washington, United States, 98405
        • Novartis Investigative Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. informed consent
  2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
  3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)

Exclusion Criteria:

  • Hypersensitivity to any of the study medications
  • Pregnancy or lactating women
  • History of malignancies
  • Use of pharmacologically active weight loss products
  • Bariatric surgery
  • Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.
  • HbA1c >10% at the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
PLACEBO_COMPARATOR: Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Drug: Placebo
Placebo
EXPERIMENTAL: LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 2.5mg bid (Epoch 3)
LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 5mg bid (Epoch 3)
LIK066 5mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 25mg bid (Epoch 3)
LIK066 25mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 50mg bid (Epoch 3)
LIK066 50mg bid dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: LIK066 bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
EXPERIMENTAL: Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.
PLACEBO_COMPARATOR: Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight at 24 Weeks
Time Frame: Baseline, Week 24 (Epoch 3)
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Baseline, Week 24 (Epoch 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
Time Frame: Baseline, Week 24
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Baseline, Week 24
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Time Frame: Baseline, Week 24
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Baseline, Week 24
Percentage Change From Baseline on Waist Circumference
Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)
Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).
Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)
Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Time Frame: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
Change From Baseline in 24-hour Urinary Glucose Excretion
Time Frame: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
Time Frame: Between Week 24 and Week 48 (Epoch 4)
Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Between Week 24 and Week 48 (Epoch 4)
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Time Frame: Baseline, Week 24
Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Baseline, Week 24
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Time Frame: Baseline, Week 24, Week 48
Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Baseline, Week 24, Week 48
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Time Frame: Week 24, Week 48
Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Week 24, Week 48
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Time Frame: Week 24, Week 48
Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
Week 24, Week 48
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Time Frame: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Time Frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Time Frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
Time Frame: Summary at Week 24 from qd or bid regimens
Observe maximum plasma concentration following administration of LIK066 (Cmax)
Summary at Week 24 from qd or bid regimens
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
Time Frame: Summary at Week 24 for qd or bid regimens
Time to reach the maximum concentration after administration of LIK066 (Tmax)
Summary at Week 24 for qd or bid regimens
Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
Time Frame: Summary at Week 24 from qd or bid regimens (0-6h)
Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Summary at Week 24 from qd or bid regimens (0-6h)
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
Time Frame: Summary at Week 24 from qd or bid regimens
Last non-zero concentration area under the curve (AUClast)
Summary at Week 24 from qd or bid regimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIK066B2201
  • 2016-002868-14 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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