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BARIOPTIMISE

CompletedPhase 4

Evaluation 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

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

NCT IDNCT03341429
Org study ID17/0238

Timeline

Milestones

Study first posted2017-11-14actual
Study start2018-08-22actual
Primary completion2019-11-28actual
Study completion2020-06-11actual
Last update posted2020-11-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

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

Patient-reported / QoL
5
Weight & body composition
4
Glycemic / diabetes
3
Cardiometabolic biomarkers
2
Other clinical outcomes
2
Heart failure
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

%WL

Time frame:24 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

%fat

Time frame:24 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Skeletal muscle mass

Time frame:24 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Bone mineral density

Time frame:24 weeks

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Glucose level

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

1 endpoint
Secondary/protocol endpoint

physical functional assessment

Time frame:24 weeks

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Leptin

Time frame:24 weeks

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Adipokines

Time frame:24 weeks

change from baseline, improvement

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

physical function assessment

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

HRQoL

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

HRQoL

Time frame:24 weeks

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

HRQoL

Time frame:24 weeks

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

HRQoL

Time frame:24 weeks

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

physical function assessment

Time frame:24 weeks

descriptive, improvement

Secondary/protocol endpoint

physical function assessment

Time frame:24 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Gut 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.