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

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• semaglutide — DRUG
  Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
• liraglutide — DRUG
  Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
• placebo — DRUG
  Once-daily subcutaneous (s.c., under the skin) administration.

Study Details

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.

Key Dates

Start date

Oct 1, 2015

Status verified

Apr 2020

Primary completion

Mar 30, 2017

Completion

Apr 12, 2017

Study Design

Enrollment

957 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sema 0.05 mg
  Dose 0.05 mg
• Experimental: Sema 0.1 mg
  Dose 0.05 or 0.1 mg with dose escalation every fourth week
• Experimental: Sema 0.2 mg
  Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week
• Experimental: Sema 0.3 mg
  Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week
• Experimental: Sema 0.4 mg
  Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week
• Experimental: Sema 0.3 mg (fast dose escalation)
  Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week
• Experimental: Sema 0.4 mg (fast dose escalation)
  Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week
• Active Comparator: Lira 3.0 mg
  Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week
• Placebo Comparator: Placebo Sema 0.05 mg
  Placebo arm matching active arm Sema 0.05 mg
• Placebo Comparator: Placebo Sema 0.1 mg
  Placebo arm matching active arm Sema 0.1 mg
• Placebo Comparator: Placebo Sema 0.2 mg
  Placebo arm matching active arm Sema 0.2 mg
• Placebo Comparator: Placebo Sema 0.3 mg
  Placebo arm matching active arm Sema 0.3 mg
• Placebo Comparator: Placebo Sema 0.4 mg
  Placebo arm matching active arm Sema 0.4 mg
• Placebo Comparator: Placebo Sema 0.3 mg (fast dose escalation)
  Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)
• Placebo Comparator: Placebo Sema 0.4 mg (fast dose escalation)
  Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)
• Placebo Comparator: Placebo Lira 3.0 mg
  Placebo arm matching active arm Lira 3.0 mg

Primary Outcome Measure

Relative Change in Body Weight (%) [ Time Frame: Week 0, Week 52 ]

Locations (22)

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