Semaglutide 2.4 mg in Patients With Poor Weight-loss

Obesity Clinical Trial

— BARI-STEP  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05073835
• Other study ID #: 142522
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 1, 2022
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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), 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Metabolic Syndrome
• Obesity
• Weight Loss

Intervention

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
Placebo

Locations

Country	Name	City	State
United Kingdom	Janine Makaronids	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Percentage of total weight loss	68 weeks
Secondary	body weight reduction =10%	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%	68 weeks
Secondary	body weight reduction =15%	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%	68 weeks
Secondary	body weight reduction =20%	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%	68 weeks
Secondary	Change in circulating HbA1c levels	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	68 weeks
Secondary	Change in circulating HbA1c levels in participants with pre-diabetes at baseline	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	68 weeks
Secondary	Change in circulating HbA1c levels in participants with T2D at baseline	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	68 weeks
Secondary	Systolic and diastolic BP	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	68 weeks
Secondary	Systolic and diastolic BP in participants with pre-existing hypertension	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	68 weeks
Secondary	pharmacological agents required for the management of hypertension	The number of pharmacological agents required for the management of hypertension in participants with pre-existing hypertension	68 weeks
Secondary	Change in circulating lipids	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	68 weeks
Secondary	Change in circulating HsCRP and inflammatory cytokines	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	68 weeks
Secondary	Changes in food craving scores assessed through power of food questionnaire	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	68 weeks
Secondary	Changes in HRQoL	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	68 weeks
Secondary	GLP-1 levels	To investigate the relationship between fasted and meal-stimulated active GLP-1 levels at baseline and %WL at 68 weeks	68 weeks