Status:
COMPLETED
Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response
Lead Sponsor:
University College, London
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery
Detailed Description
Subjects with poor weight loss response (\<20% of their total weight) following 1 year or more primary gastric bypass or primary sleeve gastrectomy, will be identified from the trial site (University ...
Eligibility Criteria
Inclusion
- 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.
- Adults, 18-64 years inclusive.
- 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.
- 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.
- 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.
- ≤5 % variation in body weight over preceding 3 months.
- Fluent in English and able to understand and complete questionnaires.
- Willing and able to provide written informed consent and comply with the trial protocol.
Exclusion
- Had a surgical procedure other than gastric bypass and sleeve gastrectomy.
- Pregnant or lactating mothers.
- Participation in other clinical intervention trial.
- Lifetime history of suicidal behaviour or severe depression assessed by direct questioning.
- Clinically significant medical abnormalities (e.g., unstable hypertension, clinically significant ECG abnormalities, liver cirrhosis, AST or ALT \> 3x the upper normal limit).
- Heart rate ≥ 100 beats/minute at screening on two separate measurements.
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Renal impairment (estimated glomerular infiltration rate (eGFR \<30 ml/min 1.73 m2)
- Known or suspected hypersensitivity to liraglutide 3.0 mg and placebo or any of the excipients involved in their formulation.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
- Personal history of pancreatitis.
- Uncontrolled hypothyroidism or hyperthyroidism.
- History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
- History of arrhythmias.
- Inflammatory bowel disease.
- Diabetic gastroparesis.
- Concomitant GLP-1 receptor agonist usage.
- Concomitant usage of medications that cause weight gain or weight loss.
- Concomitant usage of DPPIV-inhibitors.
- Insulin usage.
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03341429
Start Date
August 22 2018
End Date
June 11 2020
Last Update
November 5 2020
Active Locations (1)
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1
UCLH
London, United Kingdom, NW1 2BU