Semaglutide for people with obesity and resistant hypertension (SUPPORT): a pilot, randomized, parallel-group, integrated, multicentre clinical trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Trinity College Dublin

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

24 Apr 2025 → ongoing

Decision date (initial)

2025-01-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Health Research Board, IRELAND (HRB)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To assess the feasibility of conducting a trial to determine whether targeting obesity with semaglutide in patients with resistant hypertension improves blood pressure control versus placebo.

Conditions and MedDRA coding

Cardiovascular disorders: Hypertension and Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Obesity defined as a BMI ≥ 30kg/m2
2. Resistant hypertension defined as: o Mean home systolic BP ≥ 130 mmHg measured in duplicate at a minimum of 6 timepoints. o Prescribed three or more anti-hypertensive medications, which should include a diuretic.
3. Prescribed three or more anti-hypertensive medications at optimal doses, one of which should include a diuretic.
4. Written informed consent to partake and availability for trial duration.
5. Adults, aged ≥18 years at the time of signing informed consent.

Exclusion criteria 11

1. Comorbidities: Diabetes with a HbA1c ≥53mmol/L or a requirement for insulin treatment or diabetic retinopathy, previous pancreatitis/pancreatic cancer, end stage renal disease (eGFR <15ml/min), congestive heart failure NYHA class IV, limited life expectancy.
2. Presence or history of chronic pancreatitis or pancreatic cancer.
3. An episode of acute pancreatitis within the last 180 days.
4. Patients with severe renal impairment (eGFR < 30 ml/min1.73m2) including patients with end-stage renal disease, patients with severe hepatic impairment, congestive heart failure NYHA class IV, limited life expectancy.
5. Diabetes with a HbA1c ≥53mmol/L or a requirement for insulin treatment or diabetic retinopathy.
6. Female who is pregnant, breastfeeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
7. Hypersensitivity to semaglutide, another GLP1-RA, or excipients of Ozempic®/Wegovy®.
8. Personal/family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome
9. Previous surgery for weight reduction or major gastro-intestinal tract surgery
10. Otherwise considered unsuitable by the principal investigator or their primary doctor.
11. Treatment with any GLP-1 RA or any medication for the indication of obesity within the past 90 days before screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Blood pressure measurement: Variability in mean difference in systolic BP (SBP) after 36 weeks. Correlation between home, ambulatory and clinic SBP.
2. Trial conduct: Recruitment feasibility and reliability - numbers of participants screened, consented, randomized and with final results. Site feasibility - number of sites recruited and site performance (numbers of participants recruited).
3. Intervention acceptability: Tolerability of the intervention measured by treatment related participant discontinuation. Participant drop-out
4. Safety: Proportion, incidence and severity of serious adverse events in those who have taken at least one dose of the intervention.
5. Safety: Routine follow-up records the incidence of drug related adverse events of interest and those related to blood pressure lowering if they require medical assessment or hospital admission: Severe gastrointestinal symptoms (preventing everyday activities) • Acute pancreatitis (Atlanta classification).[Banks,2013] • Hypotensive episodes requiring medical review e.g. syncope, falls due to orthostatic symptoms • Acute kidney injury (KDIGO definition)

Secondary endpoints 3

1. Clinical: For all randomized patients administered semaglutide compared with placebo, both in addition to healthy lifestyle advice, from baseline to 36 weeks: • Mean difference in home systolic BP • Change in anti-hypertensive medications, • Mean difference in home diastolic BP, • Mean difference in body weight, • Mean difference in ambulatory* and clinic systolic and diastolic BP, • Mean difference in glycated haemoglobin (HbA1c)
2. Patient reported: Comparing the trial arm treated with semaglutide with placebo, both in addition to a healthy lifestyle intervention, from baseline to week 36 for: • Change in health-related quality-of-life using the EQ-5D-3L, • Change in health beliefs using the Beliefs about Medicines questionnaire, • Change in medication adherence using the Hill-Bone questionnaire, • Change in health lifestyle behaviours using the Best Health Program questionnaire.
3. Exploratory: Composite BP change (mean difference in SBP and mean difference in expected mean difference in BP as a result of alterations to anti-hypertensive medications using a treatment intensity score). Novel measures of BP control including SBP Load and Time in Target Range.

Investigational products

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

Test 8

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Trinity College Dublin

Sponsor organisation

Trinity College Dublin

Address

College Green

City

Dublin 2

Postcode

D02 PN40

Country

Ireland

Scientific contact point

Organisation

Trinity College Dublin

Contact name

Ruben Eavan Keane

Public contact point

Organisation

Trinity College Dublin

Contact name

Ruben Eavan Keane

Locations

1 EU/EEA country · 5 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 26 files

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

Application history

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