BARI-STEP: Semaglutide 2.4 mg in Patients With Poor Weight-loss

Sponsor
University College, London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05073835
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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), 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Semaglutide 3 mg
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 3b, double-blinded, randomised, parallel group trialPhase 3b, double-blinded, randomised, parallel group trial
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
double blinded: both participants and study doctors will be blind to group allocation
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.

Drug: Semaglutide 3 mg
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).

Placebo Comparator: Control

Placebo administration, once weekly, subcutaneous injection.

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Weight loss [68 weeks]

    Percentage of total weight loss

Secondary Outcome Measures

  1. body weight reduction ≥10% [68 weeks]

    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% [68 weeks]

    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% [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

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

  10. Change in circulating lipids [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

    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 [68 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients, ≥1 year primary RYGB or primary SG, with poor weight-loss (<20% WL) that is not caused by either a surgical or psychological problem.

  2. Adults, 18-65 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 RYGB 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UCLLondonUnited KingdomWC1E 6JF

Sponsors and Collaborators

  • University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT05073835
Other Study ID Numbers:
  • 142522
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University College, London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021