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

NCT03100058 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CLIK066B22012016-002868-14
• Study Type: interventional
• Target: 460
• Locations: 7 countries
• Sites: 83

Brief 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.

Conditions

Obesity; Overweight

Keywords

Obesity; Overweight

Outcome Measures

Primary Outcomes (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

  Baseline, Week 24 (Epoch 3)

Secondary Outcomes (19)

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

  Baseline, Week 24

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

  Baseline, Week 24

• Percentage Change From Baseline on Waist Circumference

  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)

  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)

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

Study Arms (13)

LIK066 2.5mg qd (Epoch 3)

EXPERIMENTAL

LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.

Drug: LIK066

Placebo (Epoch 3)

PLACEBO COMPARATOR

Matching placebo tablets for 24 weeks

Drug: Placebo

LIK066 10mg qd (Epoch 3)

EXPERIMENTAL

LIK066 10mg qd (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 50mg qd (Epoch 3)

EXPERIMENTAL

LIK066 50mg qd (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 150mg qd (Epoch 3)

EXPERIMENTAL

LIK066 150mg qd (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 2.5mg bid (Epoch 3)

EXPERIMENTAL

LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 5mg bid (Epoch 3)

EXPERIMENTAL

LIK066 5mg bid (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 25mg bid (Epoch 3)

EXPERIMENTAL

LIK066 25mg bid (once daily) dosing frequency for 24 weeks

Drug: LIK066

LIK066 50mg bid (Epoch 3)

EXPERIMENTAL

LIK066 50mg bid dosing frequency for 24 weeks

Drug: LIK066

LIK066 qd/LIK066 25mg qd (Epoch 4)

EXPERIMENTAL

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 bid/LIK066 35mg qd (Epoch 4)

EXPERIMENTAL

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

Placebo/LIK066 25mg qd (Epoch 4)

EXPERIMENTAL

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

Placebo/Placebo (Epoch 4)

PLACEBO COMPARATOR

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

Interventions

LIK066 DRUG

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

LIK066 10mg qd (Epoch 3); LIK066 150mg qd (Epoch 3); LIK066 2.5mg bid (Epoch 3); LIK066 2.5mg qd (Epoch 3); LIK066 25mg bid (Epoch 3); LIK066 50mg bid (Epoch 3); LIK066 50mg qd (Epoch 3); LIK066 5mg bid (Epoch 3); LIK066 bid/LIK066 35mg qd (Epoch 4); LIK066 qd/LIK066 25mg qd (Epoch 4); Placebo/LIK066 25mg qd (Epoch 4)

Placebo DRUG

Placebo

Placebo (Epoch 3); Placebo/Placebo (Epoch 4)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (83)

Novartis Investigative Site

Anniston, Alabama, 36207, United States

Location

Novartis Investigative Site

Jasper, Alabama, 35501, United States

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Novartis Investigative Site

Beverly Hills, California, 90211, United States

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Novartis Investigative Site

Carmichael, California, 95608, United States

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Novartis Investigative Site

Concord, California, 94520, United States

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Novartis Investigative Site

Los Angeles, California, 90017, United States

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Novartis Investigative Site

Northridge, California, 91325, United States

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Novartis Investigative Site

Roseville, California, 95661, United States

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Novartis Investigative Site

San Ramon, California, 94582, United States

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Novartis Investigative Site

Stockton, California, 95204, United States

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Novartis Investigative Site

Walnut Creek, California, 94598, United States

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Novartis Investigative Site

Denver, Colorado, 80246, United States

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Novartis Investigative Site

Golden, Colorado, 80401, United States

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Novartis Investigative Site

Bradenton, Florida, 34209, United States

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Novartis Investigative Site

Fort Lauderdale, Florida, 33312, United States

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Novartis Investigative Site

Port Charlotte, Florida, 33952, United States

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Novartis Investigative Site

West Palm Beach, Florida, 33401, United States

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Novartis Investigative Site

Athens, Georgia, 30606, United States

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Novartis Investigative Site

Augusta, Georgia, 30909, United States

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Novartis Investigative Site

Honolulu, Hawaii, 96814, United States

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Novartis Investigative Site

Gurnee, Illinois, 60031, United States

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Novartis Investigative Site

Springfield, Illinois, 62711, United States

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Novartis Investigative Site

Wauconda, Illinois, 60084, United States

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Novartis Investigative Site

Evansville, Indiana, 47713, United States

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Novartis Investigative Site

Evansville, Indiana, 47714, United States

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Novartis Investigative Site

Indianapolis, Indiana, 46260, United States

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Novartis Investigative Site

Louisville, Kentucky, 40213, United States

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Novartis Investigative Site

Baton Rouge, Louisiana, 70808, United States

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Novartis Investigative Site

Covington, Louisiana, 70433, United States

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Novartis Investigative Site

Hammond, Louisiana, 70403, United States

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Novartis Investigative Site

Metairie, Louisiana, 70006, United States

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Novartis Investigative Site

New Orleans, Louisiana, 70115, United States

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Novartis Investigative Site

New Orleans, Louisiana, 70119, United States

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Novartis Investigative Site

Baltimore, Maryland, 21229, United States

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Novartis Investigative Site

Beltsville, Maryland, 20705, United States

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Novartis Investigative Site

Towson, Maryland, 21204, United States

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Novartis Investigative Site

Royal Oak, Michigan, 48073, United States

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Novartis Investigative Site

City of Saint Peters, Missouri, 63303, United States

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Novartis Investigative Site

St Louis, Missouri, 63128, United States

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Novartis Investigative Site

Missoula, Montana, 59808, United States

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Novartis Investigative Site

Omaha, Nebraska, 68134, United States

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Novartis Investigative Site

New York, New York, 10016, United States

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Novartis Investigative Site

New York, New York, 10021, United States

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Novartis Investigative Site

The Bronx, New York, 10455, United States

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Novartis Investigative Site

Hickory, North Carolina, 28601, United States

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Novartis Investigative Site

Lansdale, Pennsylvania, 19446, United States

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Novartis Investigative Site

Pittsburgh, Pennsylvania, 15212, United States

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Novartis Investigative Site

Moncks Corner, South Carolina, 29464, United States

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Novartis Investigative Site

Mt. Pleasant, South Carolina, 29464, United States

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Novartis Investigative Site

Summerville, South Carolina, 29485, United States

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Novartis Investigative Site

Houston, Texas, 77081, United States

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Novartis Investigative Site

Bountiful, Utah, 84010, United States

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Novartis Investigative Site

Salt Lake City, Utah, 84102, United States

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Novartis Investigative Site

Newport News, Virginia, 23606, United States

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Novartis Investigative Site

Richmond, Virginia, 23235, United States

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Novartis Investigative Site

Richmond, Virginia, 23294, United States

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Novartis Investigative Site

Renton, Washington, 98057, United States

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Novartis Investigative Site

Tacoma, Washington, 98405, United States

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Novartis Investigative Site

Kenosha, Wisconsin, 53144, United States

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Novartis Investigative Site

Graz, 8036, Austria

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Novartis Investigative Site

Vienna, 1010, Austria

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Novartis Investigative Site

Vienna, 1030, Austria

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Novartis Investigative Site

Toronto, Ontario, M4G 3E8, Canada

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Novartis Investigative Site

Toronto, Ontario, M9W 4L6, Canada

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Novartis Investigative Site

Gatineau, Quebec, J8Y 6S8, Canada

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Novartis Investigative Site

Lévis, Quebec, G6W 5M6, Canada

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Novartis Investigative Site

Prague, Czech Republic, 128 08, Czechia

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Novartis Investigative Site

České Budějovice, 370 01, Czechia

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Novartis Investigative Site

Olomouc Lazce, 77900, Czechia

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Novartis Investigative Site

Prague, 116 94, Czechia

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Novartis Investigative Site

Prague, 13000, Czechia

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Novartis Investigative Site

Slaný, 274 01, Czechia

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Novartis Investigative Site

Csongrád, 6640, Hungary

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Novartis Investigative Site

Nyíregyháza, 4400, Hungary

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Novartis Investigative Site

Szentes, 6600, Hungary

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Novartis Investigative Site

Bratislava, 85101, Slovakia

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Novartis Investigative Site

Košice, 040 01, Slovakia

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Novartis Investigative Site

Sereď, 92601, Slovakia

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Novartis Investigative Site

Basingstoke, RG24 9DT, United Kingdom

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Novartis Investigative Site

Blackburn, BB2 1AX, United Kingdom

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Novartis Investigative Site

Exeter, EX2 5DW, United Kingdom

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Novartis Investigative Site

Rotherham, S65 1DA, United Kingdom

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Novartis Investigative Site

Stevenage, SG1 4AB, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

licogliflozin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 4, 2017
• Study Start: May 6, 2017
• Primary Completion: March 2, 2018
• Study Completion: August 2, 2018
• Last Updated: February 6, 2020
• Results First Posted: February 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (59); CA (4); AU (3); CZ (6); SL (3); GB (5); HU (3)