Phase 2 Completed N=460 Randomized Triple-blind Treatment

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

Obesity · Overweight

Source: ClinicalTrials.gov NCT03100058 ↗

Enrolled (actual)

460

Serious AEs

5.4%

Results posted

Feb 2020

Primary outcomePrimary: Percent Change From Baseline in Body Weight at 24 Weeks — -1.24; -2.04; -3.52; -4.37 Percent change — p=<0.0001

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Body Weight at 24 Weeks	-1.24; -2.04; -3.52; -4.37; -1.67; -2.51	<0.0001 sig
SECONDARY Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study	26.3; 15.8; 34.2; 42.9; 15.8; 20.5	0.099
SECONDARY Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups	31.3; 25.0; 40.0; 48.4; 6.7; 37.5	0.048 sig
SECONDARY Percentage Change From Baseline on Waist Circumference	-2.1; -2.7; -3.7; -5.6; -2.7; -4.3	0.470
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)	1.9; -0.1; -1.2; -0.8; -0.5; -1.1	0.225
SECONDARY Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)	0.1; -0.5; -0.9; -0.7; -0.3; -0.5	0.082
SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)	-1.2; -1.5; -4.9; -1.2; -0.7; 0.8	0.156
SECONDARY Change From Baseline in 24-hour Urinary Glucose Excretion	208.6; 134.6; 377.0; 306.1; 183.0; 193.8	—
SECONDARY Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)	-0.2; -0.2; -2.4; 0.4	0.355
SECONDARY Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion	49.6; 33.1; 40.2; 34.6; 44.7; 43.6	—
SECONDARY Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion	4.8; 5.0; 4.6; 5.6; 5.1; 5.2	—
SECONDARY Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion	282.1; 240.5; 254.5; 291.5; 284.0; 241.8	—
SECONDARY Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion	27.6; 30.5; 28.6; 40.2; 27.5; 30.2	—
SECONDARY Change From Baseline in Fasting Lipid Profile (Lipoproteins)	8.9; 8.13; 10.7; 8.9; 5.3; 8.1	—
SECONDARY Change From Baseline in High Sensitive C-reactive Protein (hsCRP)	0.99; 1.06; 1.31; 0.98; 1.02; 0.93	0.632
SECONDARY Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)	-3.8; 1.3; -11.5; -3.0; 2.3; 1.7	0.254
SECONDARY Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)	80.0; 128; 798; 1810; 38.6; 84.2	—
SECONDARY Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)	1.00; 1.00; 1.01; 1.02; 1.00; 1.00	—
SECONDARY Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)	196; 275; 2280; 5700; 105; 273	—
SECONDARY Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)	196; 275; 2290; 5690; 105; 273	—

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03100058). 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. Informational only — not medical advice.