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ObesityPhase 2NCT03100058

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

A Phase 2 study testing LIK066 in people with Obesity and Overweight, run by Novartis Pharmaceuticals at 83 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight
What is being tested?
LIK066
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
460 participants
Where
83 sitesin 7 countries
Study dates
6 May 2017to 2 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

83 sites in 7 countries.

83 sites in 7 countries

United States59 sites

  • Novartis Investigative Site

    Anniston, Alabama, 36207

  • Novartis Investigative Site

    Athens, Georgia, 30606

  • Novartis Investigative Site

    Augusta, Georgia, 30909

  • Novartis Investigative Site

    Baltimore, Maryland, 21229

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70808

  • Novartis Investigative Site

    Beltsville, Maryland, 20705

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Novartis Investigative Site

    Bountiful, Utah, 84010

  • Novartis Investigative Site

    Bradenton, Florida, 34209

  • Novartis Investigative Site

    Carmichael, California, 95608

  • Novartis Investigative Site

    City of Saint Peters, Missouri, 63303

  • Novartis Investigative Site

    Concord, California, 94520

  • Novartis Investigative Site

    Covington, Louisiana, 70433

  • Novartis Investigative Site

    Denver, Colorado, 80246

  • Novartis Investigative Site

    Evansville, Indiana, 47713

  • Novartis Investigative Site

    Evansville, Indiana, 47714

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33312

  • Novartis Investigative Site

    Golden, Colorado, 80401

  • Novartis Investigative Site

    Gurnee, Illinois, 60031

  • Novartis Investigative Site

    Hammond, Louisiana, 70403

  • Novartis Investigative Site

    Hickory, North Carolina, 28601

  • Novartis Investigative Site

    Honolulu, Hawaii, 96814

  • Novartis Investigative Site

    Houston, Texas, 77081

  • Novartis Investigative Site

    Indianapolis, Indiana, 46260

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Kenosha, Wisconsin, 53144

  • Novartis Investigative Site

    Lansdale, Pennsylvania, 19446

  • Novartis Investigative Site

    Los Angeles, California, 90017

  • Novartis Investigative Site

    Louisville, Kentucky, 40213

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Missoula, Montana, 59808

  • Novartis Investigative Site

    Moncks Corner, South Carolina, 29464

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464

  • Novartis Investigative Site

    New Orleans, Louisiana, 70115

  • Novartis Investigative Site

    New Orleans, Louisiana, 70119

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    New York, New York, 10021

  • Novartis Investigative Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Northridge, California, 91325

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15212

  • Novartis Investigative Site

    Port Charlotte, Florida, 33952

  • Novartis Investigative Site

    Renton, Washington, 98057

  • Novartis Investigative Site

    Richmond, Virginia, 23235

  • Novartis Investigative Site

    Richmond, Virginia, 23294

  • Novartis Investigative Site

    Roseville, California, 95661

  • Novartis Investigative Site

    Royal Oak, Michigan, 48073

  • Novartis Investigative Site

    Salt Lake City, Utah, 84102

  • Novartis Investigative Site

    San Ramon, California, 94582

  • Novartis Investigative Site

    Springfield, Illinois, 62711

  • Novartis Investigative Site

    St Louis, Missouri, 63128

  • Novartis Investigative Site

    Stockton, California, 95204

  • Novartis Investigative Site

    Summerville, South Carolina, 29485

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    The Bronx, New York, 10455

  • Novartis Investigative Site

    Towson, Maryland, 21204

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Wauconda, Illinois, 60084

  • Novartis Investigative Site

    West Palm Beach, Florida, 33401

Other trials in United States

Czechia6 sites

  • Novartis Investigative Site

    České Budějovice, 370 01

  • Novartis Investigative Site

    Olomouc Lazce, 77900

  • Novartis Investigative Site

    Prague, Czech Republic, 128 08

  • Novartis Investigative Site

    Prague, 116 94

  • Novartis Investigative Site

    Prague, 13000

  • Novartis Investigative Site

    Slaný, 274 01

Other trials in Czechia

United Kingdom5 sites

  • Novartis Investigative Site

    Basingstoke, RG24 9DT

  • Novartis Investigative Site

    Blackburn, BB2 1AX

  • Novartis Investigative Site

    Exeter, EX2 5DW

  • Novartis Investigative Site

    Rotherham, S65 1DA

  • Novartis Investigative Site

    Stevenage, SG1 4AB

Other trials in United Kingdom

Canada4 sites

  • Novartis Investigative Site

    Gatineau, Quebec, J8Y 6S8

  • Novartis Investigative Site

    Lévis, Quebec, G6W 5M6

  • Novartis Investigative Site

    Toronto, Ontario, M4G 3E8

  • Novartis Investigative Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Austria3 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Vienna, 1010

  • Novartis Investigative Site

    Vienna, 1030

Other trials in Austria

Hungary3 sites

  • Novartis Investigative Site

    Csongrád, 6640

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Szentes, 6600

Other trials in Hungary

Slovakia3 sites

  • Novartis Investigative Site

    Bratislava, 85101

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Sereď, 92601

Other trials in Slovakia

About this study

Official title: 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.

Conditions
Obesity, Overweight
Being tested
LIK066, Placebo
Keywords
Obesity, Overweight
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LIK066Drug

    LIK066 will be supplied in different doses as tablets to be taken orally.

  • PlaceboDrug

    Placebo

Study groups in NCT03100058
Study groupRoleWhat they receive
LIK066 2.5mg qd (Epoch 3)ExperimentalLIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
Receives: Drug: LIK066
Placebo (Epoch 3)Placebo comparatorMatching placebo tablets for 24 weeks
Receives: Drug: Placebo
LIK066 10mg qd (Epoch 3)ExperimentalLIK066 10mg qd (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 50mg qd (Epoch 3)ExperimentalLIK066 50mg qd (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 150mg qd (Epoch 3)ExperimentalLIK066 150mg qd (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 2.5mg bid (Epoch 3)ExperimentalLIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 5mg bid (Epoch 3)ExperimentalLIK066 5mg bid (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 25mg bid (Epoch 3)ExperimentalLIK066 25mg bid (once daily) dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 50mg bid (Epoch 3)ExperimentalLIK066 50mg bid dosing frequency for 24 weeks
Receives: Drug: LIK066
LIK066 qd/LIK066 25mg qd (Epoch 4)ExperimentalBetween 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
Receives: Drug: LIK066
LIK066 bid/LIK066 35mg qd (Epoch 4)ExperimentalBetween 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
Receives: Drug: LIK066
Placebo/LIK066 25mg qd (Epoch 4)ExperimentalBetween 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
Receives: Drug: LIK066
Placebo/Placebo (Epoch 4)Placebo comparatorBetween 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight at 24 Weeks

    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

    Measured: Baseline, Week 24 (Epoch 3)

Secondary outcomes (19)

  1. Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study

    Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline

    Measured: Baseline, Week 24

  2. Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups

    Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)

    Measured: Baseline, Week 24

  3. Percentage Change From Baseline on Waist Circumference

    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.

    Measured: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

  4. Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)

    FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).

    Measured: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

  5. Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)

    HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.

    Measured: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)

  6. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    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

    Measured: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)

  7. Change From Baseline in 24-hour Urinary Glucose Excretion

    Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.

    Measured: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)

  8. Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)

    Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)

    Measured: Between Week 24 and Week 48 (Epoch 4)

  9. Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion

    Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.

    Measured: Baseline, Week 24

  10. Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion

    Evaluation of 24-hour urinary calcium after 48 weeks of treatment

    Measured: Baseline, Week 24, Week 48

  11. Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion

    Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment

    Measured: Week 24, Week 48

  12. Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion

    Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment

    Measured: Week 24, Week 48

  13. Change From Baseline in Fasting Lipid Profile (Lipoproteins)

    Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

    Measured: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)

  14. Change From Baseline in High Sensitive C-reactive Protein (hsCRP)

    Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

    Measured: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)

  15. Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)

    Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48

    Measured: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)

  16. Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)

    Observe maximum plasma concentration following administration of LIK066 (Cmax)

    Measured: Summary at Week 24 from qd or bid regimens

  17. Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)

    Time to reach the maximum concentration after administration of LIK066 (Tmax)

    Measured: Summary at Week 24 for qd or bid regimens

  18. Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)

    Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)

    Measured: Summary at Week 24 from qd or bid regimens (0-6h)

  19. Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)

    Last non-zero concentration area under the curve (AUClast)

    Measured: Summary at Week 24 from qd or bid regimens

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start6 May 2017
  3. Primary completion2 Mar 2018
  4. Study completion2 Aug 2018

Resources

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
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03100058
Sponsor's protocol ID
CLIK066B2201
Other IDs
2016-002868-14, 2016
Status last verified
Jan 2020
First submitted
3 Mar 2017
Last updated
6 Feb 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIK066 in people with Obesity and Overweight, run by Novartis Pharmaceuticals at 83 sites in 7 countries.

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 3 inclusion and 7 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 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Czechia, United Kingdom, Canada, Austria and 2 more countries. 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 6 Feb 2020). 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?

Percent Change From Baseline in Body Weight at 24 Weeks (time frame: Baseline, Week 24 (Epoch 3)). 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 NCT03100058.

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 6 Feb 2020.

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