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NCT Number: NCT07364175

A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults

Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom. Obesity is also a serious and ongoing epidemic, with global obesity rates having more than tripled in men and doubled in women, since 1975. In the United Kingdom, 64% of the adult population are overweight or obese. Hypertension and obesity share a well-established association, with obesity being responsible for the development of hypertension in 40-78% of cases. In young adults, this link between body size and blood pressure (BP) is much stronger that in older adults. Since overweight and obesity are among the most common and modifiable causes of high BP, weight loss induced by lifestyle-changes is recommended for overweight or obese patients with hypertension. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not maintained in the majority of cases. A meta-analysis of randomised controlled trials demonstrated that lifestyle-interventions lead to an average net weight reduction of 5.1 kg, accompanied by a significant, but modest, ~4 mmHg reduction in BP. Weight loss interventions could play a crucial role in the treatment of obesity-related hypertension in young adults.

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, originally developed for the treatment of type 2 diabetes, are safe and clinically effective anti-obesity drugs. Recent data show a 10-20% placebo-adjusted reduction in body weight in overweight or obese adults without diabetes using the GLP-1 analogue semaglutide or the dual GLP-1/GIP receptor agonist tirzepatide, with the majority of weight loss achieved within the initial six months. The substantial weight loss induced by these drugs is accompanied by a significant reduction in BP. Two recent meta-analyses showed that semaglutide is associated with a ~5 mmHg placebo-adjusted reduction in clinic systolic BP (SBP). A sub-study of the SURMOUNT-1 trial reported a ~10 mmHg reduction in 24-h ambulatory SBP with tirzepatide. Most participants in these studies were normotensive or had well-controlled hypertension. Furthermore, antihypertensive medication use declined amongst those receiving anti-obesity drugs meaning the BP-lowering effect of weight loss, elicited by these drugs, is probably underestimated. These data suggest that the new anti-obesity drugs could be effective in managing overweight or obesity-related hypertension. Furthermore, it may be possible to cure hypertension in at least some young adults, removing the need for life-long antihypertensive treatment. However, the magnitude and time course of BP reduction elicited by these new anti-obesity drugs remain uncertain.

The primary aim of this feasibility study is to assess the extent and trajectory of BP reduction achieved through intensive weight loss in overweight or obese adults with stage 1 hypertension and compare this to current standard of care measures which uses anti-hypertensive medications and lifestyle advice. The study will utilise a modified trial within cohort approach, using patients based within the clinical pharmacology/hypertension service at Addenbrooke's Hospital, Cambridge.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location status: Recruiting

Location contact

James Goodman, MRCP PhD

CONTACT

[email protected]

+44 01223 336806

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility criteria for randomisation

Inclusion criteria

  • Aged 18 to 40 years (inclusive)
  • Body mass index (BMI) ≥27 kg/m2
  • Clinical diagnosis of primary (essential) hypertension as per NICE guidance
  • Unattended brachial SBP ≥135 and/or DBP ≥85 mmHg and <160/100 mmHg
  • Maximum of one antihypertensive medication

Exclusion criteria

  • Anything in medical notes suggesting unsuitable in the opinion of the investigator

Eligibility criteria for participation in weight loss arm

Inclusion criteria

  • Written informed consent
  • Aged 18 to 40 years (inclusive)
  • Body mass index ≥27 kg/m2
  • Clinical diagnosis of primary (essential) hypertension as per NICE guidance
  • Unattended brachial SBP ≥135 and/or DBP ≥85 mmHg and <160/100 mmHg
  • Maximum of one antihypertensive medication

Exclusion criteria

The presence of any of the following will preclude participant inclusion:

  • Known or suspected secondary hypertension
  • Hypersensitivity to any of the study drugs or excipients
  • Currently taking drugs likely to have interactions with tirzepatide
  • Diagnosis of type 1 or type 2 diabetes mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists
  • Prior or planned surgical, endoscopic and/or device-based therapy treatment for obesity
  • Self-reported, intentional or unintentional, change in body weight (over ~10%) within ~three months of screening
  • Known heart failure or clinically significant valvular heart disease
  • Implanted pacemaker or implantable cardioverter defibrillator (ICD)
  • Second or third-degree AV block, sino-atrial block, sick sinus syndrome
  • Known active malignancy including thyroid cancer
  • Known renal impairment (creatinine >150µmol/L)
  • Clinically significant neurological disease
  • History of scleroderma
  • Participants on anticoagulant therapy
  • Known history of pancreatitis
  • Known inflammatory bowel disease
  • History of gallstones (unless previous cholecystectomy)
  • Severe gastroparesis or gastric emptying abnormality
  • Family history of multiple endocrine neoplasia
  • Needle-phobia
  • Planned pregnancy, current pregnancy, or breastfeeding
  • Current involvement in the active treatment phase of other research studies
  • Any other clinical reason which may preclude entry in the opinion of the investigator

Treatment and study plan

Tirzepatide

Drug

2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks

Anti-Hypertensive medications

Drug

Anti-hypertensive drug therapy as per local and national guidelines

Primary outcomes

  1. Ambulatory systolic blood pressure

    Time frame: Baseline to week 24

    Change in daytime ambulatory systolic blood pressure in the weight loss arm

Secondary outcomes

  1. Ambulatory diastolic blood pressure

    Time frame: Baseline to week 24

    Change in daytime ambulatory diastolic blood pressure in the weight loss arm

  2. Clinic systolic blood pressure

    Time frame: Baseline to week 24

    Changes in clinic systolic blood pressure in the weight loss arm

  3. Clinic diastolic blood pressure

    Time frame: Baseline to week 24

    Changes in clinic diastolic blood pressure in the weight loss arm

  4. Clinic mean arterial pressure

    Time frame: Baseline to week 24

    Changes in clinic mean arterial pressure in the weight loss arm

  5. Unattended systolic blood pressure

    Time frame: Baseline to week 24

    Changes in unattended systolic blood pressure in the weight loss arm

  6. Unattended diastolic blood pressure

    Time frame: Baseline to week 24

    Changes in unattended diastolic blood pressure in the weight loss arm

  7. Unattended mean arterial pressure

    Time frame: Baseline to week 24

    Changes in unattended mean arterial pressure in the weight loss arm

  8. Body weight

    Time frame: Baseline to week 24

    Changes in body weight in the weight loss arm

  9. Body fat

    Time frame: Baseline to week 24

    Changes in body fat in the weight loss arm

  10. Waist:hip ratio

    Time frame: Baseline to week 24

    Changes in waist:hip ratio in the weight loss arm

  11. Cardiac output

    Time frame: Baseline to week 24

    Changes in cardiac output in the weight loss arm

  12. Peripheral vascular resistance

    Time frame: Baseline to week 24

    Changes in peripheral vascular resistance in the weight loss arm

  13. Pulse wave analysis / pulse wave velocity

    Time frame: Baseline to week 24

    Changes in markers of pulse wave analysis and pulse wave velocity in the weight loss arm

  14. Heart rate variability

    Time frame: Baseline to week 24

    Changes in heart rate variability in the weight loss arm

  15. Renin

    Time frame: Baseline to week 24

    Changes in plasma renin in the weight loss arm

  16. Aldosterone

    Time frame: Baseline to week 24

    Changes in plasma aldosterone in the weight loss arm

  17. Plasma metanephrines

    Time frame: Baseline to week 24

    Changes in plasma metanephrines in the weight loss arm

  18. Leptin

    Time frame: Baseline to week 24

    Changes in leptin in the weight loss arm

  19. Insulin

    Time frame: Baseline to week 24

    Changes in plasma insulin in the weight loss arm

  20. Lipid profile

    Time frame: Baseline to week 24

    Changes in the lipid profile in the weight loss arm

  21. HbA1C

    Time frame: Baseline to week 24

    Changes in HbA1C in the weight loss arm

  22. Estimated glomerular filtration rate

    Time frame: Baseline to week 24

    Changes in eGFR in the weight loss arm

  23. N-terminal pro-B-type natriuretic peptide

    Time frame: Baseline to week 24

    Changes in NT-proBNP in the weight loss arm

  24. Urine albumin:creatinine ratio

    Time frame: Baseline to week 24

    Change in urine albumin:creatinine ratio in the weight loss arm

  25. 24-hour urine sodium

    Time frame: Baseline to week 24

    Change in 24-hour urine sodium in the weight loss arm

  26. 24-hour urine aldosterone

    Time frame: Baseline to week 24

    Change in 24-hour urine aldosterone in the weight loss arm

  27. Antihypertensive medications

    Time frame: Baseline to week 24

    Change in number of antihypertensive medications

  28. Quality of life measures

    Time frame: Baseline to week 24

    Changes in quality of life questionnaire scores in the weight loss arm

  29. Ambulatory systolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in ambulatory sytolic blood pressure

  30. Ambulatory diastolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in ambulatory diastolic blood pressure

  31. Clinic systolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in clinic systolic blood pressure

  32. Clinic diastolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in clinic diastolic blood pressure

  33. Clinic mean arterial pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in clinic mean arterial pressure

  34. Unattended systolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in unattended systolic blood pressure

  35. Unattended diastolic blood pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in unattended diastolic blood pressure

  36. Unattended mean arterial pressure

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in mean arterial pressure

  37. Body weight

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group body weight

  38. Body fat

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in body fat

  39. Waist:hip ratio

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in waist:hip ratio

  40. Cardiac output

    Time frame: At week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in cardiac output

  41. Peripheral vascular resistance

    Time frame: At week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in peripheral vascular resistance

  42. Pulse wave analysis / pulse wave velocity

    Time frame: At week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in markers of pulse wave analysis and pulse wave velocity

  43. Heart rate variability

    Time frame: At week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in heart rate variability

  44. Plasma renin

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in plasma renin

  45. Plasma aldosterone

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in plasma aldosterone

  46. Plasma metanephrines

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in plasma metanephrines

  47. Lipid profile

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in lipid profile

  48. HbA1C

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in HbA1C

  49. Estimated glomerular filtration rate

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in eGFR

  50. N-terminal pro-B-type natriuretic peptide

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in NT-proBNP

  51. Urine albumin:creatinine ratio

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in urine albumin:creatinine ratio

  52. 24-hour urine sodium

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in 24-hour urine sodium

  53. 24-hour urine aldosterone

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in 24-hour urine aldosterone

  54. Number of antihypertensive medications

    Time frame: Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in the number of anti-hypertensive medications

  55. Quality of life measures

    Time frame: At week 24 (weight loss arm) and 6 months (standard of care arm)

    Between-group comparison in quality of life questionnaire scores

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study

Acronym: SOLUTION-Pilot

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 23, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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