Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
• placebo — DRUG
  Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
• liraglutide — DRUG
  Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
• placebo — DRUG
  Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Study Details

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Key Dates

Start date

Jun 1, 2011

Status verified

Dec 2017

Primary completion

Mar 18, 2013

Completion

Mar 2, 2015

Study Design

Enrollment

3,731 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
• Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
• Placebo Comparator: Liraglutide Placebo, no Pre-diabetes
• Experimental: Liraglutide 3.0mg, Pre-diabetes
• Placebo Comparator: Liraglutide Placebo, Pre-diabetes

Primary Outcome Measure

Change From Baseline in Fasting Body Weight [ Time Frame: Week 0, Week 56 ]

Locations (73)

Find similar trials in Birmingham, AL

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