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

Liraglutide for low-responders after bariatric surgery - LIBAR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000548-71-NL

Enrollment

100

Registered

2020-12-21

Start date

2021-01-25

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid obesity

Interventions

Trade Name: Saxenda Pharmaceutical Form: Suspension for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient is =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in patients who are low responders 3 months after bariatric surgery.;Secondary Objective: There are three secondary objectives: a) To describe the persistence of therapy and the average daily dose patients used b) To describe the gastro-intestinal symptoms and eating habits of the study group c) To study the weight loss at 12, 18, 24 and 36 months after surgery ;Primary end point(s): %TWL at 9 months after surgery.;Timepoint(s) of evaluation of this end point: 9 months after surgery.	—

Measure

Time frame

Main Objective: To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in patients who are low responders 3 months after bariatric surgery.;Secondary Objective: There are three secondary objectives: a) To describe the persistence of therapy and the average daily dose patients used b) To describe the gastro-intestinal symptoms and eating habits of the study group c) To study the weight loss at 12, 18, 24 and 36 months after surgery ;Primary end point(s): %TWL at 9 months after surgery.;Timepoint(s) of evaluation of this end point: 9 months after surgery.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Medication use: during whole treatment program Questionnaire: start of study and 14 weeks after start TWL: 12-, 18-, 24-, and 36-months after surgery. ;Secondary end point(s): Secondary endpoints will include medication use: - Number and percentage of patients in whom dose escalation was according to protocol - Number and percentage of patients who used 3.0 mg as a daily dose for 22 weeks - Average daily dose of all patients (after the dose escalation) Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the “eating habits and physical problems” scales of the BODY-Q questionnaire which will be administered at study start and at 14 weeks after study start. Weight loss (%TWL) at longer follow-up will also be studied. For this study we will collect measurements at the following moments: 12-, 18-, 24-, and 36-months after surgery.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Medication use: during whole treatment program Questionnaire: start of study and 14 weeks after start TWL: 12-, 18-, 24-, and 36-months after surgery. ;Secondary end point(s): Secondary endpoints will include medication use: - Number and percentage of patients in whom dose escalation was according to protocol - Number and percentage of patients who used 3.0 mg as a daily dose for 22 weeks - Average daily dose of all patients (after the dose escalation) Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the “eating habits and physical problems” scales of the BODY-Q questionnaire which will be administered at study start and at 14 weeks after study start. Weight loss (%TWL) at longer follow-up will also be studied. For this study we will collect measurements at the following moments: 12-, 18-, 24-, and 36-months after surgery.

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Countries

Netherlands

Contacts

Public ContactValerie Monpellier

Nederlandse Obesitas Kliniek

vmonpellier@obesitaskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026