Phase 3
Completed N=3,731
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT01272219 ↗
Enrolled (actual)
3,731
Serious AEs
10.9%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline in Fasting Body Weight — -7.98; -2.62 percent change — p=<0.0001
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Fasting Body Weight |
-7.98; -2.62 | <0.0001 sig |
| PRIMARY Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. |
63.2; 27.1 | <0.0001 sig |
| PRIMARY Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight |
33.1; 10.6 | <0.0001 sig |
| PRIMARY Proportion of Subjects With Onset of Type 2 Diabetes |
26; 46 | <.0001 sig |
| SECONDARY Change From Baseline in Waist Circumference (cm) |
-8.19; -3.94 | — |
| SECONDARY Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) |
-6.87; -3.37 | — |
| SECONDARY Pre-diabetes Status After 56 Weeks of Treatment |
78.3; 50.9; 20.6; 46.1; 0.9; 1.8 | — |
| SECONDARY Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment |
65.9; 36.3; 31.3; 54.9; 1.1; 2.6 | — |
| SECONDARY Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) |
-6.14; -1.89 | — |
| SECONDARY Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline) |
49.6; 23.7; 24.8; 9.9 | — |
| SECONDARY Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) |
0.69; 2.91; 0.28 | — |
| SECONDARY Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) |
-8.44; -6.77; -3.11 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained
- Body Mass Index (BMI) of 30.0 kg/m^2 or above
- Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
- Stable body weight
- Preceding failed dietary effort
Exclusion Criteria
- Known type 1 or type 2 diabetes
- Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
- Screening calcitonin of 50 ng/L or above
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- History of acute or chronic pancreatitis
- Obesity induced by drug treatment
- Use of approved weight lowering pharmacotherapy
- Previous surgical treatment of obesity
- History of major depressive disorder or suicide attempt
- Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
Data sourced from ClinicalTrials.gov (NCT01272219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.