Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response

Short name BARIOPTIMISE

NCTNCT03341429 (opens ClinicalTrials.gov in a new tab)Other id17/0238
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
70 participants (actual)
Sponsor
University College, London · Other
Design
Randomized · Quadruple masking
Countries
1 country

United Kingdom

Start
22 Aug 2018
Primary completion
28 Nov 2019
Completion
11 Jun 2020
First posted
14 Nov 2017
Last update posted
5 Nov 2020
Conditions
Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 4

    BARIOPTIMISE

    NCT03341429

    22 Aug 2018 to 11 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Liraglutide Pen Injector [Saxenda]Drug
  • PlaceboDrug

Arms2

  • Experimental

    Treatment

    Daily subcutaneous injection of liraglutide 3.0 mg Study dosing of liraglutide: Week 1: 0.6 mg once daily Week 2: 1.2 mg once daily Week 3: 1.8 mg once daily Week 4: 2.4 mg once daily Week 5-24: 3.0 mg once daily In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.

  • Placebo comparator

    Control

    Daily subcutaneous injection of placebo; the same dosage regimen as treatment to be followed. In addition to the daily injection of liraglutide/placebo, participants in both groups will be advised to cut down approximately 500 calories from their usual food intake and to achieve a minimum of 150 minutes per week of physical activity.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. %WL

    Time frame · 24 weeks

    Registry description

    The primary objective of this trial is to compare the efficacy of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration, as an adjunct to diet and exercise, on %WL in participants with poor weight-loss and a sub-optimal active GLP-1 response following primary RYGB or SG at the end of the 24-week treatment period.

Secondary outcomes(17)

  1. %fat

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on % body fat assessed using DXA scanning

  2. Skeletal muscle mass

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on skeletal muscle mass assessed using DXA scanning

  3. Bone mineral density

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on bone mineral density assessed using DXA scanning

  4. Glucose level

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of glucose assessed using blood test

  5. Insulin

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of insulin assessed using blood test

  6. HbA1c

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of HbA1c assessed using blood test

  7. Leptin

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of leptin assessed using blood test

  8. Gut Hormones

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of gut hormones assessed using blood test

  9. Adipokines

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on fasted and meal-stimulated levels of adipokines assessed using blood test

  10. physical functional assessment

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the 6-minute walk test (6-MWT)

  11. physical function assessment

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the sit-to-stand test (STS Test)

  12. physical function assessment

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using hand-grip strength

  13. physical function assessment

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on physical functioning assessed using the Paffenbarger Physical Activity Questionnaire (PPAQ)

  14. HRQoL

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using an adapted Client Service Receipt Inventory (CSRI)

  15. HRQoL

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using EuroQol-5D (ED5DEQ-5D)

  16. HRQoL

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using Impact of weight on quality of life-lite (IWQOL-Lite)

  17. HRQoL

    Time frame · 24 weeks

    Registry description

    To compare the effect of 24-weeks of subcutaneous liraglutide 3.0 mg versus placebo administration as an adjunct to diet and exercise at the end of the 24-week treatment period on health related quality of life assessed using Beck depression inventory (BDI)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

5 results

Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs Placebo in Patients With Poor Weight Loss Following Metabolic Surgery: The BARI-OPTIMISE Randomized Clinical Trial.

Mok et al. 2023JAMA surgerycited by 131

PMID 37494014PMC10372755DOI 10.1001/jamasurg.2023.2930PUB-37494014

CC BY5 results
Download PDFSee results (5)

Indexing hint: Randomized controlled trial · 2016

6 results

Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

Blackman et al. 2016International journal of obesity (2005)cited by 398

PMID 27005405PMC4973216DOI 10.1038/ijo.2016.52PUB-27005405

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

More studies

1 study on this page

PubMed tag: none · 2013

Short-term use of liraglutide in the management of patients with weight regain after bariatric surgery.

Pajecki et al. 2013Revista do Colegio Brasileiro de Cirurgioescited by 67

PMID 23912365DOI 10.1590/s0100-69912013000300005PUB-23912365

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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. Exclusion Criteria: 1. Had a surgical procedure other than gastric bypass and sleeve gastrectomy. 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.