Prevent from home: young person and buddies’ cardiovascular health improvement feasibility study (PHYLLIS)
Hypertension in pregnancy, gestational diabetes
Current interventions as of 24/07/2026: Part B: Intervention: (i) SGLT2i, oral dapagliflozin 10 mg once a day for 26 weeks; (ii) GLP-1, tirzepatide, weekly subcutaneous injections for 26 weeks. Starting dose will be 2.5mg for at least 4 weeks, with subsequent increases of 2.5 mg every 4 weeks based on symptom tolerance and weight loss response, up to a maximum dose of 15 mg. 52 weeks study duration with maximum duration on SGLT2i of 26 weeks; (ii) 52 weeks study duration with maximum duration on GLP-1 of 26 weeks _____ Previous interventions: 1:1 randomisation of postpartum individuals, who had pregnancies complicated by hypertensive disorders of pregnancy and/ or gestational diabetes, who have completed breastfeeding, to either 10 mg dapagliflozin once daily for 26 weeks, or standard care, with both arms offered additional support for participation in the form of remote monitoring, peer support or co-recruitment (“study buddy”). The follow-up period will be 52 weeks in total.
Current key inclusion criteria as of 24/07/2026: Part A: 1. Person with current pregnancy, or within six weeks of pregnancy, complicated by hypertension 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Body mass index >23kg/m² Part B: Postpartum person (including people not identifying as female) with: 1. Previous pregnancy complicated by hypertension in pregnancy and/or gestational diabetes (defined by National Institute for Health and Care Excellence) ≤12-months 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Completed breastfeeding 5. Body mass index ≥27kg/m² Study buddy: Study buddy (co-recruitment as selected by the postpartum person): 1. Age 18 years – 60 years 2. Body mass index ≥27kg/m² 3. Able to provide written informed consent 4. Person with ≥1 of the following pre-cardiovascular disease risk factor (NICE 2024): 4.1. Pre-hypertension (systolic blood pressure 120- 139 and/or diastolic blood pressure 80-89 mmHg) 4.2. Parent or sibling with diabetes or body mass index >30kg/m2 AND age > 25 years if African Caribbean, Black African, or South Asian or age > 40 years if any other ethnicity AND Haemoglobin A1c of 42-47 mmol/mol (6-6.4%) 4.3. Postpartum person with previous pregnancy complicated by hypertension in pregnancy and/or gestational diabetes >12-months _____ Previous key inclusion criteria: Part A: 1. Person with current pregnancy, or within 6 weeks of pregnancy, complicated by hypertension 2. Able to provide written informed consent 3. Age ≥ 18 years 4. Body mass index >17 kg/m² Part B: Postpartum person (including people not identifying as female): 1. Previous pregnancy complicated by HDP and/or GDM (defined by NICE) ≤12 months 2. Able to provide written informed consent 3. Age ≥18 years 4. Completed breastfeeding 5. Body mass index >17 kg/m2 Study buddy: 1. Able to provide written informed consent 2. Age 18 – 60 years with ≥1 pre-CVD risk factor: 2.1. Pre-hypertension (systolic BP 120-139 mmHg and/or diasto
Current key exclusion criteria as of 24/07/2026: Part A: Pregnant or postpartum person (including people not identifying as female) with: 1. Diabetes (Type-1 or 2) 2. Chronic Kidney Disease or Heart failure and recommended routine SGLT2i 3. Severe hepatic impairment 4. Allergy to dapagliflozin (SGLT2i), tirzepatide (GLP-1) or its excipients 5. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 6. Contraindication to postpartum enalapril, amlodipine, nifedipine, or labetalol - including allergy 7. Moving away from study site within 12 months 8. Planning pregnancy ≤6-months Part B: Postpartum person and study-buddies with: 1. Diabetes (Type-1 or 2), or history of diabetic ketoacidosis or hyperosmolar state or diabetic coma 2. Chronic Kidney Disease or Heart failure and recommended routine SGLT2i 3. Liver disease (AST or ALT > 2x upper limit of normal) 4. History of acute or chronic pancreatitis 5. Severe gastrointestinal disease 6. Oral medications with a narrow therapeutic window (e.g. warfarin, digoxin) 7. Any drug associated with hypoglycaemia (e.g. antimalarial agents, lithium) 8. Allergy to dapagliflozin (SGLT2i), tirzepatide (GLP-1), or its excipients 9. Pregnant*, planning pregnancy within 6 months or breastfeeding (females of childbearing potential* with a positive pregnancy test at screening) 10. Moving away from study site within 12 months 11. Severe hepatic impairment 12. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption 13. Use of GLP-1 receptor agonists within the past 3 months 14. History of organ transplantation * A pregnancy test (urine) will be performed for all persons of childbearing potential at all onsite visits and monthly at home tests performed. Study drugs will not be dispensed without a negative pregnancy test. Women randomised to tirzepatide on oral contraception will be counselled on the potential for reduced efficacy and advised to use a barrier metho