Semaglutide 2.4mg for low responders after bariatric surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Zuyderland Medisch Centrum

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Health Care [N] - Environment and Public Health [N06]

Trial duration

11 Mar 2025 → ongoing

Decision date (initial)

2024-09-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-502164-20-01

WHO UTN

U1111-1273-2041

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To study the weight change from 3 to 18 months after surgery (% total weight loss, TWL) in low responders after bariatric surgery who are treated with Semaglutide 2.4 mg and a lifestyle intervention and compare change in weight to patients receiving placebo and a lifestyle intervention.

Secondary objectives 6

1. To study the weight loss at 3, 6, 12 and 18 months after surgery (before semaglutide start and 3, 9 and 15 months after semaglutide start)
2. To study metabolic health before surgery, at start of treatment and 6, 12 and 18 months after surgery (before semaglutide start and 3, 9 and 15 months after semaglutide start)
3. To study health-related quality of life (HRQOL) and gastro-intestinal symptoms before surgery, at start of treatment and 6, 12 and 18 months after surgery (before semaglutide start and 3, 9 and 15 months after semaglutide start)
4. To evaluate the change in cardiorespiratory fitness level of the participants before surgery, at start of treatment program and 6, 12 and 18 months after surgery ( before semaglutide start and 3, 9 and 15 months after semaglutide start)
5. To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, at start of treatment with semaglutide and 15 months after semaglutide start
6. To describe the persistence of therapy and average weekly dose

Conditions and MedDRA coding

obesity

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient is ≥18 and <75 years old
2. BMI before surgery was ≥ 35.0 kg/m2
3. Patient is treated with group consultation at the Dutch Obesity Clinic (DOC)
4. Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)
5. Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.

Exclusion criteria 10

1. Type 1 or type 2 diabetes
2. Decreased renal function (creatinine clearance < 30 ml/min)
3. Liver failure (all)
4. Congestive heart failure or angina pectoris NYHA class III and IV
5. Malignancy in history
6. Pancreatitis (in history)
7. Pregnancy / breast-feeding
8. Inflammatory Bowel Disease
9. Thyroid malignancy in history
10. Use of warfarin or other coumarin derivates

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main endpoint is change in %TWL from 3 to 18 months after bariatric surgery (15 months/ 68 weeks after semaglutide start). Assessment of bodyweight is standard part of treatment.

Secondary endpoints 7

1. The secondary endpoints are %TWL at 3, 6, 12 and 18 months, metabolic health, quality of life and gastro-intestinal symptoms, cardiorespiratory fitness, liver fat and liver stiffness, and persistence of therapy (see attachment 1).
2. Body weight and BMI will be measured before surgery and 3, 6, 12 and 18 months after surgery. %TWL at 3, 6, 12 and 18 months after surgery will be calculated using the weight at start of treatment. Furthermore, waist circumference and waist/hip ratio will be measured at start of the treatment and at all follow up moments.
3. Metabolic health will be defined by using the following parameters: blood pressure, HbA1c, glucose, triglycerides and LDL, HDL and total cholesterol. Hypertension and dyslipidemia will be recorded at all follow-up moments to assess whether there is improvement or remission of comorbid conditions in patients who have those comorbid conditions.
4. Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the “eating habits and physical problems” scales of the BODY-Q questionnaire. This same questionnaire will also be used to study HRQoL (see attachment 2). Before surgery and at 3 (start of study), 6, 12 and 18 months the HRQoL and gastro-intestinal symptoms will be assessed.
5. Cardiorespiratory Fitness will be assessed before surgery, and at 3 (start of study), 6, 12 and 18 months after surgery. During the Åstrand test, participants cycle for 6 min on a cycle ergometer on submaximal level. After the test, VO2max is calculated by combining the patient’s characteristics (age, sex, weight, and fat-free mass (FFM)) with outcomes of the Åstrand test (level of resistance and heart rate).
6. Liver fat and liver stiffness will be assessed at the start of the study and after using semaglutide for 68 weeks. Using vibration controlled transient elastography this parameter will be assessed. Vibration controlled transient elastography (VCTE) is a diagnostically accurate method to assess liver fat and liver stiffness. All values will be expressed in kPa.
7. For this we will assess: - Number and percentage of patients in whom dose escalation was according to protocol - Number and percentage of patients who used 2.4 mg as a weekly dose for 52 weeks - Average weekly dose of all patients (after the dose escalation)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Zuyderland Medisch Centrum

Sponsor organisation

Stichting Zuyderland Medisch Centrum

Address

Henri Dunantstraat 5

City

Heerlen

Postcode

6419 PC

Country

Netherlands

Scientific contact point

Organisation

Stichting Zuyderland Medisch Centrum

Contact name

Bureau Wetenschappelijk Onderzoek

Public contact point

Organisation

Stichting Zuyderland Medisch Centrum

Contact name

Bureau Wetenschappelijk Onderzoek

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications