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Trial · Interventional

Active, not recruitingPhase 3Registry data

Semaglutide 2.4 mg in Patients With Poor Weight-loss

Short name BARI-STEP

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
70 participants (actual)
Sponsor
University College, London · Other
Design
Randomized · Triple masking
Countries
1 country

United Kingdom

Start
1 Nov 2022
Primary completion
Mar 2025 (estimated)
Completion
Sept 2025 (estimated)
First posted
12 Oct 2021
Last update posted
6 Dec 2024
Conditions
Obesity · Diabetes · Metabolic Syndrome

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 3

    BARI-STEP

    NCT05073835

    1 Nov 2022 to est. Sept 2025

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 semaglutide 3.0 mg/ml in patients with poor weight-loss following bariatric surgery. The primary aim of this trial is to determine whether, and the extent to which, 68 weeks of subcutaneous semaglutide 3.0 mg/ml causes greater percentage weight loss (%WL), reduction in adiposity, improvement in metabolic and inflammatory indices and health-related quality of life (HRQoL) than placebo, in patients with poor weight loss following gastric bypass or sleeve gastrectomy.

Interventions

  • Semaglutide 3 mgDrug
  • PlaceboDrug

Arms2

  • Experimental

    Intervention

    Semaglutide 2.4mg/week subcutaneous injection for 68 weeks. The treatment includes an initial 16-week escalation phase followed by 52 weeks of treatment at study dose, i.e., 2.4mg/week.

  • Placebo comparator

    Control

    Placebo administration, once weekly, subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Weight loss

    Time frame · 68 weeks

    Registry description

    Percentage of total weight loss

Secondary outcomes(14)
  1. body weight reduction ≥10%

    Time frame · 68 weeks

    Registry description

    To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥10%

  2. body weight reduction ≥15%

    Time frame · 68 weeks

    Registry description

    To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥15%

  3. body weight reduction ≥20%

    Time frame · 68 weeks

    Registry description

    To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥20%

  4. Change in circulating HbA1c levels

    Time frame · 68 weeks

    Registry description

    The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c

  5. Change in circulating HbA1c levels in participants with pre-diabetes at baseline

    Time frame · 68 weeks

    Registry description

    The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with pre-diabetes at baseline

  6. Change in circulating HbA1c levels in participants with T2D at baseline

    Time frame · 68 weeks

    Registry description

    The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with diabetes at baseline

  7. Systolic and diastolic BP

    Time frame · 68 weeks

    Registry description

    The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP

  8. Systolic and diastolic BP in participants with pre-existing hypertension

    Time frame · 68 weeks

    Registry description

    The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP in participants with pre-existing hypertension

  9. pharmacological agents required for the management of hypertension

    Time frame · 68 weeks

    Registry description

    The number of pharmacological agents required for the management of hypertension in participants with pre-existing hypertension

  10. Change in circulating lipids

    Time frame · 68 weeks

    Registry description

    To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon circulating lipids

  11. Change in circulating HsCRP and inflammatory cytokines

    Time frame · 68 weeks

    Registry description

    To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon inflammatory markers

  12. Changes in food craving scores assessed through power of food questionnaire

    Time frame · 68 weeks

    Registry description

    To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon food cravings

  13. Changes in HRQoL

    Time frame · 68 weeks

    Registry description

    To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HRQoL

  14. GLP-1 levels

    Time frame · 68 weeks

    Registry description

    To investigate the relationship between fasted and meal-stimulated active GLP-1 levels at baseline and %WL at 68 weeks

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

4 results

Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial.

Stanley et al. 2026Nature medicinecited by 1

PMID 42174253PMC13375533DOI 10.1038/s41591-026-04416-4PUB-42174253

CC BY4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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