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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-05

Study Completion Date

2016-04-04

Brief Summary

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

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Detailed Description

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Conditions

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Elevated Body Mass Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: LIK066 150 mg once daily (qd)

LIK066 150 mg qd within 15 minutes before starting lunch

Group Type EXPERIMENTAL

LIK066

Intervention Type DRUG

LIK066 25 mg tablets

Part 1: Placebo once daily

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

Group Type PLACEBO_COMPARATOR

LIK066

Intervention Type DRUG

LIK066 25 mg tablets

Part 2: LIK066 75 mg twice daily (bid)

LIK066 75 mg bid before breakfast and dinner

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo tablets

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

LIK066 50 mg tid before all 3 meals;

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo tablets

Part 2: Placebo three times daily

Matching placebo tablets tid before meals.

Group Type PLACEBO_COMPARATOR

LIK066

Intervention Type DRUG

LIK066 25 mg tablets

Interventions

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LIK066

LIK066 25 mg tablets

Intervention Type DRUG

Placebo

Matching placebo tablets

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No