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

NCT02470403 | Completed Phase 2 Results

• 1 other identifier: CLIK066X2201
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elevated Body Mass Index

Keywords

dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (4)

• Part 1: Percent Change in Body Weight From Baseline to Week 12

  Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as \[(post baseline- Baseline) /Baseline\] \* 100. A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate.

  Baseline, Week 12 (Day 85)

• Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death

  This endpoint reports patients with at least one AE (any AE), serious AE and death.

  12 weeks

• Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)

  Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose. Percent change is calculated as \[(post baseline- Baseline) /Baseline\] \* 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate.

  Baseline, Week 2 (Day 14)

• Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death

  This endpoint reports patients with at least one AE (any AE), serious AE and death

  2 weeks

Secondary Outcomes (13)

• Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms

  Baseline, Week 2

• Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study

  Day 84

• Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study

  Day 84

• Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study

  Day 84

• Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study

  Day 84

Study Arms (5)

Part 1: LIK066 150 mg once daily (qd)

EXPERIMENTAL

LIK066 150 mg qd within 15 minutes before starting lunch

Drug: LIK066

Part 1: Placebo once daily

PLACEBO COMPARATOR

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

Drug: LIK066

Part 2: LIK066 75 mg twice daily (bid)

EXPERIMENTAL

LIK066 75 mg bid before breakfast and dinner

Drug: Placebo

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

EXPERIMENTAL

LIK066 50 mg tid before all 3 meals;

Drug: Placebo

Part 2: Placebo three times daily

PLACEBO COMPARATOR

Matching placebo tablets tid before meals.

Drug: LIK066

Interventions

LIK066 DRUG

LIK066 25 mg tablets

Part 1: LIK066 150 mg once daily (qd); Part 1: Placebo once daily; Part 2: Placebo three times daily

Placebo DRUG

Matching placebo tablets

Part 2: LIK066 50 mg three times daily (tid); Part 2: LIK066 75 mg twice daily (bid)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Lincoln, Nebraska, 68502, United States

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Interventions

licogliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Study Director

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: June 5, 2015
• Primary Completion: April 4, 2016
• Study Completion: April 4, 2016
• Last Updated: January 5, 2021
• Results First Posted: May 12, 2017

Record last verified: 2019-03

Locations

US (1)