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BARI-STEP

Active not recruitingPhase 3

Semaglutide 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.

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

NCT IDNCT05073835
Org study ID142522

Timeline

Milestones

Study first posted2021-10-12actual
Study start2022-11-01actual
Last update posted2024-12-06actual
Primary completion2025-03estimated (month precision)
Study completion2025-09estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

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

Weight & body composition

4 endpoints
Primary/protocol endpoint

Weight loss

Time frame:68 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

body weight reduction ≥10%

Time frame:68 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

body weight reduction ≥15%

Time frame:68 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

body weight reduction ≥20%

Time frame:68 weeks

≥20% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in circulating HbA1c levels

Time frame:68 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Systolic and diastolic BP

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

Systolic and diastolic BP in participants with pre-existing hypertension

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

pharmacological agents required for the management of hypertension

Time frame:68 weeks

descriptive

Secondary/protocol endpoint

Change in circulating lipids

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Changes in food craving scores assessed through power of food questionnaire

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in HRQoL

Time frame:68 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

GLP-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.

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.