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

Novartis

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: LIK066; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03100058

2016-002868-14 (EudraCT Number)

CLIK066B2201

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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460 participants in 13 patient groups, including a placebo group

LIK066 2.5mg qd (Epoch 3)

Experimental group

Description:

LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.

Treatment:

Drug: LIK066

Placebo (Epoch 3)

Placebo Comparator group

Description:

Matching placebo tablets for 24 weeks

Treatment:

Drug: Placebo

LIK066 10mg qd (Epoch 3)

Experimental group

Description:

LIK066 10mg qd (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 50mg qd (Epoch 3)

Experimental group

Description:

LIK066 50mg qd (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 150mg qd (Epoch 3)

Experimental group

Description:

LIK066 150mg qd (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 2.5mg bid (Epoch 3)

Experimental group

Description:

LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 5mg bid (Epoch 3)

Experimental group

Description:

LIK066 5mg bid (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 25mg bid (Epoch 3)

Experimental group

Description:

LIK066 25mg bid (once daily) dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 50mg bid (Epoch 3)

Experimental group

Description:

LIK066 50mg bid dosing frequency for 24 weeks

Treatment:

Drug: LIK066

LIK066 qd/LIK066 25mg qd (Epoch 4)

Experimental group

Description:

Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily

Treatment:

Drug: LIK066

LIK066 bid/LIK066 35mg qd (Epoch 4)

Experimental group

Description:

Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily

Treatment:

Drug: LIK066

Placebo/LIK066 25mg qd (Epoch 4)

Experimental group

Description:

Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily

Treatment:

Drug: LIK066

Placebo/Placebo (Epoch 4)

Placebo Comparator group

Description:

Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily

Treatment:

Drug: Placebo