← Trials/Trial dossier/NCT05073835
BARI-STEP
Active not recruitingPhase 3Semaglutide 2.4 mg in Patients With Poor Weight-loss
BARI-STEP:A Double-blinded, Randomised, Placebo-controlled Trial of Semaglutide 2.4 mg in Patients With Poor Weight-loss Following Bariatric Surgery.
Lead sponsor
Asset
Semaglutide
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 primary GB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.
2. Adults, 18-65 years inclusive.
3. Females of childbearing potential and female partners of male participants must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) (Appendix 2) from the time consent is signed until 2 months after treatment discontinuation.
4. Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation. 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. A self-reported ≤5 % variation in body weight over preceding 3 months.
6. Fluent in English and able to understand and complete questionnaires.
7. Participants capable to provide written informed consent and comply with the trial protocol.
Exclusion criteria
1. Bariatric surgical procedure other than GB and SG, or revision bariatric surgery of any operation type.
2. Personal history of type I diabetes or type II diabetes mellitus currently treated with insulin.
3. Concomitant use of GLP-1R agonist or DPPIV-inhibitors.
4. Female who is pregnant, breast-feeding, or intends to become pregnant.
5. Current participation in other clinical intervention trial.
6. History of suicidal attempt in the previous 5 years or untreated severe depression or mental health condition assessed by direct questioning.
7. Symptomatic gallstone disease
8. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
9. Renal impairment measured as glomerular infiltration rate (eGFR <15 ml/min 1.73 m2
10. Known or suspected hypersensitivity to semaglutide or any of the excipients involved in their formulation.
11. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
12. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
13. Personal history of acute pancreatitis 180 days before screening or chronic pancreatitis.
14. Uncontrolled thyroid disease.
15. History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
16. Untreated clinically significant arrhythmias.
17. Diabetic gastroparesis.
18. Concomitant usage of medications that cause weight gain or weight loss.
19. Known or suspected abuse of alcohol or recreational drugs.
20. Severe hepatic impairment diagnosed via liver function blood tests and clinical evaluation
21. Any additional factor, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the trial protocol.
Endpoints (15)
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 endpointsWeight loss
Time frame:68 weeks
Body weight, % change
percent change from baseline, improvement
body weight reduction ≥10%
Time frame:68 weeks
≥10% weight-loss responders
threshold achievement, improvement
body weight reduction ≥15%
Time frame:68 weeks
≥15% weight-loss responders
threshold achievement, improvement
body weight reduction ≥20%
Time frame:68 weeks
≥20% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
3 endpointsChange in circulating HbA1c levels
Time frame:68 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in circulating HbA1c levels in participants with pre-diabetes at baseline
Time frame:68 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in circulating HbA1c levels in participants with T2D at baseline
Time frame:68 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
5 endpointsSystolic and diastolic BP
Time frame:68 weeks
change from baseline, improvement
Systolic and diastolic BP in participants with pre-existing hypertension
Time frame:68 weeks
change from baseline, improvement
pharmacological agents required for the management of hypertension
Time frame:68 weeks
descriptive
Change in circulating lipids
Time frame:68 weeks
change from baseline, improvement
Change in circulating HsCRP and inflammatory cytokines
Time frame:68 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Patient-reported / QoL
2 endpointsChanges in food craving scores assessed through power of food questionnaire
Time frame:68 weeks
change from baseline, improvement
Changes in HRQoL
Time frame:68 weeks
change from baseline, improvement
Other (unclassified)
1 endpointGLP-1 levels
Time frame:68 weeks
concentration, descriptive
Publications (1)
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
- PMID42174253via clinicaltrials gov reference derived
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.