Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: semaglutide; Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453711

2014-001540-38 (EudraCT Number)

NN9536-4153

U1111-1155-4660 (Other Identifier)

Details and patient eligibility

About

This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.

Enrollment: 957 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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957 participants in 16 patient groups, including a placebo group

Sema 0.05 mg

Experimental group

Description:

Dose 0.05 mg

Treatment:

Drug: semaglutide

Sema 0.1 mg

Experimental group

Description:

Dose 0.05 or 0.1 mg with dose escalation every fourth week

Treatment:

Drug: semaglutide

Sema 0.2 mg

Experimental group

Description:

Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week

Treatment:

Drug: semaglutide

Sema 0.3 mg

Experimental group

Description:

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week

Treatment:

Drug: semaglutide

Sema 0.4 mg

Experimental group

Description:

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week

Treatment:

Drug: semaglutide

Sema 0.3 mg (fast dose escalation)

Experimental group

Description:

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week

Treatment:

Drug: semaglutide

Sema 0.4 mg (fast dose escalation)

Experimental group

Description:

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week

Treatment:

Drug: semaglutide

Lira 3.0 mg

Active Comparator group

Description:

Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week

Treatment:

Drug: liraglutide

Placebo Sema 0.05 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.05 mg

Treatment:

Drug: placebo

Placebo Sema 0.1 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.1 mg

Treatment:

Drug: placebo

Placebo Sema 0.2 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.2 mg

Treatment:

Drug: placebo

Placebo Sema 0.3 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.3 mg

Treatment:

Drug: placebo

Placebo Sema 0.4 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.4 mg

Treatment:

Drug: placebo

Placebo Sema 0.3 mg (fast dose escalation)

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)

Treatment:

Drug: placebo

Placebo Sema 0.4 mg (fast dose escalation)

Placebo Comparator group

Description:

Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)

Treatment:

Drug: placebo

Placebo Lira 3.0 mg

Placebo Comparator group

Description:

Placebo arm matching active arm Lira 3.0 mg

Treatment:

Drug: placebo