iraglutide for patients who have undergone bariatric surgery and do not achieve sufficient weight loss.

Phase 1

• Conditions: Morbid obesity; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2020-000548-71-NL
• Lead Sponsor: ederlandse Obesitas Kliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Patient is =18 and <75 years old
•BMI before surgery was = 35 kg/m2
•Patient is treated with group consultation at the NOK
•Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
•Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Type 1 or type 2 diabetes
•Decreased renal function (creatinine clearance < 30 ml/min)
•Liver failure (all)
•Congestive heart failure or angina pectoris NYHA class III and IV
•Malignancy in history
•Pancreatitis (in history)
•Pregnancy / breast-feeding
•Inflammatory Bowel Disease
•Thyroid malignancy in history
•Use of warfarin or other coumarin derivates

Study & Design

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