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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT03100058

Run by

Novartis Pharmaceuticals

People needed

460

Starts

2017-05-06

Expected to finish

2018-08-02

Last updated by the study team

2020-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Novartis Investigative Site — Jasper, Alabama, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Carmichael, California, United States
• Novartis Investigative Site — Concord, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Northridge, California, United States
• Novartis Investigative Site — Roseville, California, United States
• Novartis Investigative Site — San Ramon, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Golden, Colorado, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Athens, Georgia, United States
• Novartis Investigative Site — Augusta, Georgia, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Gurnee, Illinois, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Wauconda, Illinois, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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