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BARIOPTIMISE
CompletedPhase 4Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response
BARI-OPTIMISE: 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
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
70
actual
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (18)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpoints%WL
Time frame:24 weeks
Body weight, % change
percent change from baseline, improvement
%fat
Time frame:24 weeks
Total fat mass
change from baseline, improvement
Skeletal muscle mass
Time frame:24 weeks
Lean mass
change from baseline, improvement
Bone mineral density
Time frame:24 weeks
change from baseline, improvement
Glycemic / diabetes
3 endpointsGlucose level
Time frame:24 weeks
change from baseline, improvement
Insulin
Time frame:24 weeks
change from baseline, improvement
HbA1c
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Heart failure
1 endpointphysical functional assessment
Time frame:24 weeks
6-minute walk distance
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsLeptin
Time frame:24 weeks
Leptin, change
change from baseline, improvement
Adipokines
Time frame:24 weeks
change from baseline, improvement
Patient-reported / QoL
5 endpointsphysical function assessment
Time frame:24 weeks
change from baseline, improvement
HRQoL
Time frame:24 weeks
change from baseline, improvement
HRQoL
Time frame:24 weeks
EQ-5D index
change from baseline, improvement
HRQoL
Time frame:24 weeks
IWQOL-Lite total
change from baseline, improvement
HRQoL
Time frame:24 weeks
change from baseline, improvement
Other clinical outcomes
2 endpointsphysical function assessment
Time frame:24 weeks
descriptive, improvement
physical function assessment
Time frame:24 weeks
change from baseline, improvement
Other (unclassified)
1 endpointGut Hormones
Time frame:24 weeks
change from baseline, improvement
Publications (19)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- JAMA surgery2023 Oct 1PMID37494014doi:10.1001/jamasurg.2023.2930via clinicaltrials gov reference derived + pubmed nct search
- International journal of obesity (2005)2016 Aug (month)PMID27005405doi:10.1038/ijo.2016.52via CT.gov background
- Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2015 Jun (month)PMID25840670doi:10.1007/s11605-015-2808-1via CT.gov background
- Scandinavian journal of clinical and laboratory investigation2014 Apr (month)PMID24472033doi:10.3109/00365513.2013.877594via CT.gov background
- International journal of obesity (2005)2013 Nov (month)PMID23419600doi:10.1038/ijo.2013.15via CT.gov background
- Revista do Colegio Brasileiro de Cirurgioes2013 May-Jun (year)PMID23912365doi:10.1590/s0100-69912013000300005via CT.gov background
- Deutsches Arzteblatt international2009 Oct (month)PMID19890430doi:10.3238/arztebl.2009.0641via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.