The additive effect of the appetite hormone GLP-1 (liraglutide) and exercise on maintenance of weight loss and on health parameters after a low calorie diet

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005585-32-DK
• Lead Sponsor: Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-11
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

BMI > 32 and < 43 (kg/m2), age > 18 and < 65 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
•Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
•Severe renal impairment (creatinine clearance (GFR) <30 mL/min)
•Severe hepatic impairment
•Inflammatory bowel disease
•Diabetic gastroparesis
•Cancer
•Chronic obstructive lung disease
•Psychiatric disease, a history of major depressive or other severe psychiatric disorders
•The use of medications that cause clinically significant weight gain or loss
•Previous bariatric surgery
•A history of idiopathic acute pancreatitis
•A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
•Osteoarthritis which is judged to be too severe to manage the exercise programme. As intended per study design the intervention will include a 5% weight loss prior to randomization, thus it is expected that possible participants with mild form of osteoarthritis will be able to manage exercise prescriptions.
•Pregnancy, expecting pregnancy or breast feeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). Adequate contraception must be used throughout the study period and at least 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda). Allergy to any of the ingredients/excipients.
•Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide
•Regular exercise training at high intensity (e.g. spinning) >2 hours per week.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified