A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

Novartis

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: LIK066

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320941

CLIK066B1201

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Enrollment: 126 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
• BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m^2 at least one obesity-related comorbidity
• Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
• Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
• Visceral fat area ≥ 100 cm^2
• Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

Exclusion criteria

• Pregnancy or lactating women
• Use of pharmacologically active weight-loss medications
• Bariatric surgery
• Ketoacidosis, lactic acidosis, hyperosmolar coma
• Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
• Gastro-intestinal (GI) disorders associated with chronic diarrhea
• Congestive heart failure, New York Heart Association (NYHA) class III or IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 5 patient groups, including a placebo group

LIK066 2.5 mg

Experimental group

Description:

Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.

Treatment:

Drug: LIK066

LIK066 10 mg

Experimental group

Description:

Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.

Treatment:

Drug: LIK066

LIK066 25 mg

Experimental group

Description:

Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.

Treatment:

Drug: LIK066

LIK066 50 mg

Experimental group

Description:

Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.

Treatment:

Drug: LIK066

Placebo

Placebo Comparator group

Description:

Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

Treatment:

Drug: Placebo