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ObesityPhase 3BARI-STEPNCT05073835

Semaglutide 2.4 mg in Patients With Poor Weight-loss

A Phase 3 study testing Semaglutide 3 mg in people with Obesity and Diabetes, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Diabetes, Metabolic Syndrome
What is being tested?
Semaglutide 3 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2022to 9 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Adults, 18-65 years inclusive.
  • 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.
  • 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.
  • A self-reported ≤5 % variation in body weight over preceding 3 months.
  • Fluent in English and able to understand and complete questionnaires.
  • Participants capable to provide written informed consent and comply with the trial protocol.

Who cannot join

  • Bariatric surgical procedure other than GB and SG, or revision bariatric surgery of any operation type.
  • Personal history of type I diabetes or type II diabetes mellitus currently treated with insulin.
  • Concomitant use of GLP-1R agonist or DPPIV-inhibitors.
  • Female who is pregnant, breast-feeding, or intends to become pregnant.
  • Current participation in other clinical intervention trial.
  • History of suicidal attempt in the previous 5 years or untreated severe depression or mental health condition assessed by direct questioning.
Show all 21Show fewer
  • Symptomatic gallstone disease
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
  • Renal impairment measured as glomerular infiltration rate (eGFR <15 ml/min 1.73 m2
  • Known or suspected hypersensitivity to semaglutide or any of the excipients involved in their formulation.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  • 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.
  • Personal history of acute pancreatitis 180 days before screening or chronic pancreatitis.
  • Uncontrolled thyroid disease.
  • History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
  • Untreated clinically significant arrhythmias.
  • Diabetic gastroparesis.
  • Concomitant usage of medications that cause weight gain or weight loss.
  • Known or suspected abuse of alcohol or recreational drugs.
  • Severe hepatic impairment diagnosed via liver function blood tests and clinical evaluation
  • Any additional factor, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the trial protocol.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Janine Makaronids

    London, WC1E 6JF

Other trials in United Kingdom

About this study

Official title: BARI-STEP:A Double-blinded, Randomised, Placebo-controlled Trial of Semaglutide 2.4 mg in Patients With Poor Weight-loss Following Bariatric Surgery.

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.

Being tested
Semaglutide 3 mg, Placebo
Keywords
obesity, diabetes, semaglutide
Medical subject headings
Obesity, Diabetes Mellitus, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide 3 mgDrug

    Semaglutide 2.4 mg/week, subcutaneous injection. Treatment dose: 16 weeks of dose escalation + 52 weeks of study dose (i.e., 2.4 mg/week).

  • PlaceboDrug

    Placebo

Study groups in NCT05073835
Study groupRoleWhat they receive
InterventionExperimentalSemaglutide 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.
Receives: Drug: Semaglutide 3 mg
ControlPlacebo comparatorPlacebo administration, once weekly, subcutaneous injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Weight Change

    Weight change = [(Weight at Visit 68 minus weight at baseline)/ weight at baseline]*100. Positive values represent weight gain and negative values represent weight loss.

    Measured: Baseline and week 68

Secondary outcomes (12)

  1. Categorical Weight Loss

    Cumulative percentage of participants who met the criteria for each weight loss threshold (<10%, ≥10%, ≥15%, ≥20%) at 68 weeks

    Measured: Baseline to 68 weeks

  2. Body Mass Index (BMI)

    Change in Body Mass Index from baseline to 68 weeks

    Measured: Baseline to 68 weeks

  3. Body Composition

    Change in body composition (measured by Bioelectrical Impedance Analysis) from baseline to 68 weeks

    Measured: Baseline to 68 weeks

  4. Blood Pressure Change

    Change in systolic and diastolic Blood Pressure from baseline to 68 weeks. Blood pressure change = Week 68 value minus Baseline value

    Measured: Baseline to 68 weeks

  5. Cardiovascular Outcome - Heart Rate

    Change in heart rate from baseline to 68 weeks

    Measured: baseline to 68 weeks

  6. HbA1c

    Change in HbA1c from baseline to 68 weeks

    Measured: Baseline to 68 weeks

  7. Lipid Profile

    Mean changes in total cholesterol and triglycerides from baseline to 68 weeks

    Measured: Baseline to 68 weeks

  8. High-sensitivity C-reactive Protein (hsCRP)

    Mean change in High-sensitivity C-reactive protein (hsCRP) from baseline to 68 weeks

    Measured: Baseline to 68 weeks

  9. Change in IWQOL-Lite (Impact of Weight on Quality of Life)

    The 'Impact of Weight on Quality of Life' is a 5 point Likert scale ranging from 1 = "Never true" to 5 = "Always true". It consist of five subscales (physical function, self-esteem, sexual life, public distress and work). Average scores are computed if a minimum of 50% of the items for each scale are answered, and for the total score only if 75% of all items are completed. The average score is multiplied by the total number of items for each scale. The total score is a mean of all available items averaged together. The averaged scores are then transformed and reversed, to be from 0 lowest (worst), to 100 highest (best) quality of life. The change in IQWOL-Lite scores from baseline to 68 weeks was calculated by week 68 score minus baseline score".

    Measured: Baseline to 68 weeks

  10. Change in Systolic Blood Pressure and Diastolic Blood Pressure in Participants With Pre-existing Hypertension

    Change in systolic and diastolic BP from baseline to 68 weeks in participants with pre-existing hypertension.

    Blood pressure change = Week 68 value minus Baseline value

    Measured: Baseline to 68 weeks

  11. HbA1c in Participants With Pre-existing Type 2 Diabetes

    Change in HbA1c from baseline to 68 weeks in participants with pre-existing Type 2 Diabetes.

    HbA1c change = Week 68 value minus Baseline value

    Measured: Baseline to 68 weeks

  12. Change in Circulating HbA1c Levels in Participants With Pre-diabetes

    Change in circulating HbA1c levels in participants with pre-diabetes from baseline to 68 weeks

    Measured: Baseline to 68 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start1 Nov 2022
  3. Primary completion9 Apr 2025
  4. Study completion9 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 3b, double-blinded, randomised, parallel group trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073835
Sponsor's protocol ID
142522
Acronym
BARI-STEP
Status last verified
Aug 2026
First submitted
15 Sep 2021
Last updated
26 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Stanley C, Mallik R, Hamid N, Jassil FC, Reuven V, Ruwona T, Dicken SJ, Qamar S, Norton B, Kingett H, Pucci A, Magee C, Boniface D, Batterham RL, Devalia K, Mok J, Elkalaawy M, Loy J, Jenkinson A, Markakis H, Adamo M, Brown A, Makaronidis J. Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial. Nat Med. 2026 Jul;32(7):2662-2672. doi: 10.1038/s41591-026-04416-4. Epub 2026 May 22.

    PubMed 42174253

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide 3 mg in people with Obesity and Diabetes, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Weight Change (time frame: Baseline and week 68). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05073835, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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