Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index

Novartis

Status and phase: Completed; Phase 2

Conditions: Elevated Body Mass Index

Treatments: Drug: Placebo; Drug: LIK066

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470403

CLIK066X2201

Details and patient eligibility

About

A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)

Enrollment: 181 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
• Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6 mmol/L), or HbA1c > 5.7% and < 10% at screening.
• Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
• If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
• Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening

Key Exclusion Criteria:

• Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders
• Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption
• Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder
• Pregnant or nursing (lactating) women, and women of child-bearing potential

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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181 participants in 5 patient groups, including a placebo group

Part 1: LIK066 150 mg once daily (qd)

Experimental group

Description:

LIK066 150 mg qd within 15 minutes before starting lunch

Treatment:

Drug: LIK066

Part 1: Placebo once daily

Placebo Comparator group

Description:

Matching placebo tablets of LCZ696 150 mg within 15 minutes before starting lunch.

Treatment:

Drug: LIK066

Part 2: LIK066 75 mg twice daily (bid)

Experimental group

Description:

LIK066 75 mg bid before breakfast and dinner

Treatment:

Drug: Placebo

Part 2: LIK066 50 mg three times daily (tid)

Experimental group

Description:

LIK066 50 mg tid before all 3 meals;

Treatment:

Drug: Placebo

Part 2: Placebo three times daily

Placebo Comparator group

Description:

Matching placebo tablets tid before meals.

Treatment:

Drug: LIK066