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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03100058
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
• Scientific title: A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo
• Date of first enrolment: May 6, 2017
• Target sample size: 460
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03100058
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, Czechia, Hungary, Slovakia, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. informed consent

2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia,
pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)

3. 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Overweight

Intervention(s)

Drug: LIK066

Drug: Placebo

Primary Outcome(s)

Percent Change From Baseline in Body Weight at 24 Weeks [Time Frame: Baseline, Week 24 (Epoch 3)]

Secondary Outcome(s)

Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM) [Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)]

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study [Time Frame: Baseline, Week 24]

Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax) [Time Frame: Summary at Week 24 from qd or bid regimens]

Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups [Time Frame: Baseline, Week 24]

Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax) [Time Frame: Summary at Week 24 for qd or bid regimens]

Change From Baseline in High Sensitive C-reactive Protein (hsCRP) [Time Frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)]

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM) [Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)]

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion [Time Frame: Baseline, Week 24, Week 48]

Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t) [Time Frame: Summary at Week 24 from qd or bid regimens (0-6h)]

Change From Baseline in Fasting Lipid Profile (Lipoproteins) [Time Frame: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)]

Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion [Time Frame: Week 24, Week 48]

Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol) [Time Frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)]

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion [Time Frame: Week 24, Week 48]

Percentage Change From Baseline on Waist Circumference [Time Frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)]

Change From Baseline in 24-hour Urinary Glucose Excretion [Time Frame: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)]

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [Time Frame: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)]

Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion [Time Frame: Baseline, Week 24]

Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4) [Time Frame: Between Week 24 and Week 48 (Epoch 4)]

Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast) [Time Frame: Summary at Week 24 from qd or bid regimens]

Secondary ID(s)

CLIK066B2201

2016-002868-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03100058