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Clinical Trial NCT07364175 (SOLUTION-Pilot) for Hypertension, Obesity & Overweight is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults (SOLUTION-Pilot) 60 Lifestyle
Clinical Trial NCT07364175 (SOLUTION-Pilot) is an interventional study for Hypertension, Obesity & Overweight that is recruiting. It started on January 1, 2026 with plans to enroll 60 participants. Led by Cambridge University Hospitals NHS Foundation Trust, it is expected to complete by January 1, 2029. The latest data from ClinicalTrials.gov was last updated on January 29, 2026.
Brief Summary
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 r...Show More
Official Title
Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study
Conditions
HypertensionObesity & OverweightOther Study IDs
- SOLUTION-Pilot
- R+D: A097457, REC: 25/WA/0268
NCT ID Number
Start Date (Actual)
2026-01
Last Update Posted
2026-01-29
Completion Date (Estimated)
2029-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
hypertension
obesity
overweight
tirzepatide
GLP-1
obesity
overweight
tirzepatide
GLP-1
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTirzepatide [weight loss arm] 6 months of treatment with a combined GLP-1/GIP receptor agonist, tirzepatide | Tirzepatide 2.5mg for 4 weeks, 5mg for 4 weeks, 7.5mg for 4 weeks, 10mg for 12 weeks |
Active ComparatorLifestyle advice and anti-hypertensive medications [standard of Care arm] | Anti-Hypertensive medications Anti-hypertensive drug therapy as per local and national guidelines |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ambulatory systolic blood pressure | Change in daytime ambulatory systolic blood pressure in the weight loss arm | Baseline to week 24 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Ambulatory diastolic blood pressure | Change in daytime ambulatory diastolic blood pressure in the weight loss arm | Baseline to week 24 |
Clinic systolic blood pressure | Changes in clinic systolic blood pressure in the weight loss arm | Baseline to week 24 |
Clinic diastolic blood pressure | Changes in clinic diastolic blood pressure in the weight loss arm | Baseline to week 24 |
Clinic mean arterial pressure | Changes in clinic mean arterial pressure in the weight loss arm | Baseline to week 24 |
Unattended systolic blood pressure | Changes in unattended systolic blood pressure in the weight loss arm | Baseline to week 24 |
Unattended diastolic blood pressure | Changes in unattended diastolic blood pressure in the weight loss arm | Baseline to week 24 |
Unattended mean arterial pressure | Changes in unattended mean arterial pressure in the weight loss arm | Baseline to week 24 |
Body weight | Changes in body weight in the weight loss arm | Baseline to week 24 |
Body fat | Changes in body fat in the weight loss arm | Baseline to week 24 |
Waist:hip ratio | Changes in waist:hip ratio in the weight loss arm | Baseline to week 24 |
Cardiac output | Changes in cardiac output in the weight loss arm | Baseline to week 24 |
Peripheral vascular resistance | Changes in peripheral vascular resistance in the weight loss arm | Baseline to week 24 |
Pulse wave analysis / pulse wave velocity | Changes in markers of pulse wave analysis and pulse wave velocity in the weight loss arm | Baseline to week 24 |
Heart rate variability | Changes in heart rate variability in the weight loss arm | Baseline to week 24 |
Renin | Changes in plasma renin in the weight loss arm | Baseline to week 24 |
Aldosterone | Changes in plasma aldosterone in the weight loss arm | Baseline to week 24 |
Plasma metanephrines | Changes in plasma metanephrines in the weight loss arm | Baseline to week 24 |
Leptin | Changes in leptin in the weight loss arm | Baseline to week 24 |
Insulin | Changes in plasma insulin in the weight loss arm | Baseline to week 24 |
Lipid profile | Changes in the lipid profile in the weight loss arm | Baseline to week 24 |
HbA1C | Changes in HbA1C in the weight loss arm | Baseline to week 24 |
Estimated glomerular filtration rate | Changes in eGFR in the weight loss arm | Baseline to week 24 |
N-terminal pro-B-type natriuretic peptide | Changes in NT-proBNP in the weight loss arm | Baseline to week 24 |
Urine albumin:creatinine ratio | Change in urine albumin:creatinine ratio in the weight loss arm | Baseline to week 24 |
24-hour urine sodium | Change in 24-hour urine sodium in the weight loss arm | Baseline to week 24 |
24-hour urine aldosterone | Change in 24-hour urine aldosterone in the weight loss arm | Baseline to week 24 |
Antihypertensive medications | Change in number of antihypertensive medications | Baseline to week 24 |
Quality of life measures | Changes in quality of life questionnaire scores in the weight loss arm | Baseline to week 24 |
Ambulatory systolic blood pressure | Between-group comparison in ambulatory sytolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Ambulatory diastolic blood pressure | Between-group comparison in ambulatory diastolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Clinic systolic blood pressure | Between-group comparison in clinic systolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Clinic diastolic blood pressure | Between-group comparison in clinic diastolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Clinic mean arterial pressure | Between-group comparison in clinic mean arterial pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Unattended systolic blood pressure | Between-group comparison in unattended systolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Unattended diastolic blood pressure | Between-group comparison in unattended diastolic blood pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Unattended mean arterial pressure | Between-group comparison in mean arterial pressure | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Body weight | Between-group body weight | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Body fat | Between-group comparison in body fat | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Waist:hip ratio | Between-group comparison in waist:hip ratio | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Cardiac output | Between-group comparison in cardiac output | At week 24 (weight loss arm) and 6 months (standard of care arm) |
Peripheral vascular resistance | Between-group comparison in peripheral vascular resistance | At week 24 (weight loss arm) and 6 months (standard of care arm) |
Pulse wave analysis / pulse wave velocity | Between-group comparison in markers of pulse wave analysis and pulse wave velocity | At week 24 (weight loss arm) and 6 months (standard of care arm) |
Heart rate variability | Between-group comparison in heart rate variability | At week 24 (weight loss arm) and 6 months (standard of care arm) |
Plasma renin | Between-group comparison in plasma renin | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Plasma aldosterone | Between-group comparison in plasma aldosterone | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Plasma metanephrines | Between-group comparison in plasma metanephrines | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Lipid profile | Between-group comparison in lipid profile | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
HbA1C | Between-group comparison in HbA1C | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Estimated glomerular filtration rate | Between-group comparison in eGFR | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
N-terminal pro-B-type natriuretic peptide | Between-group comparison in NT-proBNP | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Urine albumin:creatinine ratio | Between-group comparison in urine albumin:creatinine ratio | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
24-hour urine sodium | Between-group comparison in 24-hour urine sodium | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
24-hour urine aldosterone | Between-group comparison in 24-hour urine aldosterone | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Number of antihypertensive medications | Between-group comparison in the number of anti-hypertensive medications | Change from baseline to week 24 (weight loss arm) and 6 months (standard of care arm) |
Quality of life measures | Between-group comparison in quality of life questionnaire scores | At week 24 (weight loss arm) and 6 months (standard of care arm) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
• 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
Cambridge University Hospitals NHS Foundation TrustNational Institute for Health Research, United KingdomStudy Responsible Party
James Goodman, Principal Investigator, Consultant Physician and Clinical Pharmacologist, Cambridge University Hospitals NHS Foundation Trust
No contact data.
1 Study Locations in 1 Countries
Cambridgeshire
Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
James Goodman, MRCP PhD, Contact, +44 01223 336806, [email protected]
Recruiting