Daily injection of liraglutide 3.0 mg versus placebo in patients with poor weight loss response and suboptimal blood level of a gut hormone that controls appetite called glucagon-like peptide-1 (GLP-1) following weight-loss surgery.
- Conditions
- Obesity.MedDRA version: 20.0Level: LLTClassification code 10068900Term: Bariatric surgerySystem Organ Class: 100000004865MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-002407-10-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
1.Patients, 1 year or more after primary RYGB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.
2.Adults, 18-64 years inclusive.
3.Suboptimal nutrient-stimulated GLP-1 response assessed by a meal test. Suboptimal active GLP-1 response is defined as a =2-fold increase in active GLP-1 circulating levels between time 0 and time 30 minutes.
4.Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control, abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
5.Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
6.=5 % variation in body weight over preceding 3 months.
7.Fluent in English and able to understand and complete questionnaires.
8.Willing and able to provide written informed consent and comply with the trial protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Had a surgical procedure other than gastric bypass and sleeve gastrectomy,or revision bariatric surgery of any operation type.
2.Pregnant or lactating mothers.
3.Participation in other clinical intervention trial.
4.Lifetime history of suicidal behaviour or severe depression assessed by direct questioning.
5.Clinically significant medical abnormalities (e.g., unstable hypertension, clinically significant ECG abnormalities, liver cirrhosis, AST or ALT > 3x the upper normal limit).
6.Heart rate = 100 beats/minute at screening on two separate measurements.
7.Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg).
8.Renal impairment (estimated glomerular infiltration rate (eGFR <30 ml/min 1.73 m2)
9.Known or suspected hypersensitivity to liraglutide 3.0 mg and placebo or any of the excipients involved in their formulation.
10.Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
11.Personal history of pancreatitis.
12.Uncontrolled hypothyroidism or hyperthyroidism.
13.History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
14.History of arrhythmias.
15.Inflammatory bowel disease.
16.Diabetic gastroparesis.
17.Concomitant GLP-1 receptor agonist usage.
18.Concomitant usage of medications that cause weight gain or weight loss.
19.Concomitant usage of DPPIV-inhibitors.
20.Insulin usage.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method