Phase 2 N=181 Randomized Quadruple-blind Other

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

Elevated Body Mass Index

Bottom Line

View on ClinicalTrials.gov: NCT02470403 ↗

Enrolled (actual)

181

Serious AEs

0.5%

Results posted

May 2017

Primary outcome: Primary: Part 1: Percent Change in Body Weight From Baseline to Week 12 — -5.51; 0.19; -6.55; 0.29 percent change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LIK066 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Percent Change in Body Weight From Baseline to Week 12	-5.51; 0.19; -6.55; 0.29; -4.46; 0.09	<0.001 sig
PRIMARY Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death	43; 39; 1; 0; 0; 0	—
PRIMARY Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)	-1.17; -1.73; -1.71; 0.66	<0.001 sig
PRIMARY Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death	40; 43; 10; 0; 0; 0	—
SECONDARY Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms	-1.99; -1.73; -1.46; -1.70	—
SECONDARY Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study	1230; 1220; 1230	—
SECONDARY Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study	3.02; 4.02; 3.02	—
SECONDARY 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	11600; 12800; 12100	—
SECONDARY 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	11600; 12800; 12100	—
SECONDARY The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study	14.1; 13.2; 13.7	—
SECONDARY The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study	110; 106; 109	—
SECONDARY Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study	728; 513; 767; 517; 747; 515	—
SECONDARY Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study	1.00; 1.00; 1.00; 0.983; 1.00; 1.00	—
SECONDARY Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study	3160; 3910; 3280; 3870; 3220; 3890	—
SECONDARY Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study	3170; 1340; 3290; 1350; 3230; 1350	—
SECONDARY The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study	24.3; 39.3; 23.8; 40.5; 24.1; 39.9	—
SECONDARY The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study	132; 274; 127; 519; 130; 390	—

Summary

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

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT02470403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.