Phase 3
Completed N=282
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT02963935 ↗
Enrolled (actual)
282
Serious AEs
2.8%
Results posted
Jul 2019
Primary outcomePrimary: Change in Body Weight (%) — -7.4; -4.0; -9.1; -4.8 percent change — p=0.0003
◆ Published Evidence
Highly cited
190citations · ~32 / year
Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.
Summary
This trial is conducted in the United States of America (USA). The purpose of the trial is to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule).
Linked Publications
-
Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) |
-7.4; -4.0; -9.1; -4.8 | 0.0003 sig |
| PRIMARY Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56 |
61.47; 38.82; 64.08; 38.57 | 0.0003 sig |
| SECONDARY Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56 |
30.45; 19.75; 33.80; 19.29 | 0.0469 sig |
| SECONDARY Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56 |
18.11; 8.92; 20.42; 8.57 | 0.0311 sig |
| SECONDARY Proportion of Subjects Losing 4% or More of Baseline Body Weight |
78.73; 52.70 | <0.0001 sig |
| SECONDARY Change in Waist Circumference (cm) |
-9.27; -6.91; -10.46; -7.24 | 0.0063 sig |
| SECONDARY Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score |
3.55; 4.21; 4.03; 4.77 | 0.8137 |
| SECONDARY Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score |
13.5; 15.5; 15.2; 17.5 | 0.6916 |
| SECONDARY Change in Six Minutes Walking Distance Test (6MWT) |
47; 49; 53; 51 | 0.6986 |
| SECONDARY Change From Baseline in HbA1c (%) |
-0.2; -0.1 | — |
| SECONDARY Change From Baseline in FPG (mg/dL) |
-4.04; -0.28 | — |
| SECONDARY Change From Baseline sBP (mmHg) |
-2; -1 | — |
| SECONDARY Change From Baseline dBP (mmHg) |
-1; -1 | — |
| SECONDARY Change From Baseline in Lipids -Total Cholesterol |
-0.01; 0.00 | — |
| SECONDARY Change From Baseline in Lipids - LDL Cholesterol |
-0.01; -0.01 | — |
| SECONDARY Change From Baseline in Lipids - HDL Cholesterol |
0.06; 0.02 | — |
| SECONDARY Change From Baseline in Lipids - VLDL Cholesterol |
-0.06; -0.01 | — |
| SECONDARY Change From Baseline in Lipids - TG |
-0.19; -0.01 | — |
| SECONDARY Change From Baseline in Lipids - FFA |
-0.07; -0.06 | — |
| SECONDARY Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains) |
0.67; 1.21; 1.89; 1.08; -0.93; -0.68 | — |
| SECONDARY Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS)) |
3.41; 3.83 | — |
| SECONDARY Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS) |
-1.22; -2.20 | — |
| SECONDARY Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score |
10.1; 8.6 | — |
| SECONDARY Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score |
13.5; 12.4 | — |
| SECONDARY Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score |
13.2; 12.8 | — |
| SECONDARY Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score |
NA; NA | — |
| SECONDARY Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score |
38.7; 37.9 | — |
| SECONDARY Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score |
43.7; 41.4 | — |
| SECONDARY Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score |
20.4; 9.3 | — |
| SECONDARY Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score |
37.3; 34.3 | — |
| SECONDARY Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product |
49.5; 46.8 | — |
| SECONDARY Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet |
38.4; 36.1 | — |
| SECONDARY Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity |
29.0; 30.0 | — |
| SECONDARY Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity |
24.0; 24.5 | — |
| SECONDARY Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product |
22.9; 24.0 | — |
| SECONDARY AEs From Randomisation Until and Including the Follow-up Period |
867; 601 | — |
| SECONDARY Change in Physical Examination |
108; 121; 34; 19; 0; 0 | — |
| SECONDARY Change in Resting Pulse |
2; 1 | — |
| SECONDARY Change in ECG |
100; 91; 41; 49; 1; 0 | — |
| SECONDARY Change in Laboratory Measurements: Haematology (Haemoglobin Blood) |
-0.2; -0.1 | — |
| SECONDARY Change in Laboratory Measurements: Haematology (Haematocrit Blood) |
-1.5; -0.9 | — |
| SECONDARY Change in Laboratory Measurements: Haematology (Erythrocytes) |
-0.11; -0.08 | — |
| SECONDARY Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes) |
4; 0; -0.14; -0.11 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Albumin) |
-0.1; -0.1 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase) |
-2; -1; -5; -4; 4; 1 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine) |
1.1; 1.0; -1.8; -1.4 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea) |
0.01; 0.01; -0.0; -0.0; -0.0; -0 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid) |
-2.51; -0.85; -0.6; -0.3 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum) |
2; 2 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Calcitonin) |
0.2; 0.1 | — |
| SECONDARY Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone) |
-0.2313; 0.2685 | — |
Eligibility 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
- BMI above or equal to 30 kg/m^2
- Male or female, age 18 years or older at the time of signing informed consent
Exclusion Criteria
- HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
- Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
- Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- History of pancreatitis (acute or chronic)
- History of major depressive disorder within the past 2 years
- Any lifetime history of a suicide attempt
- Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
- History of malignancy (except for non-melanoma skin cancer) within the past 5 years
Data sourced from ClinicalTrials.gov (NCT02963935) and the linked publication. 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.