DelfaGLP-1 Atlas

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SOLUTION-Pilot

RecruitingPhase NA

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

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Hypertension, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Systolic BP, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07364175
Org study IDR+D: A097457, REC: 25/WA/0268

Timeline

Milestones

Study first posted2026-01-23actual
Last update posted2026-01-29actual
Study start2026-01estimated (month precision)
Primary completion2027-01estimated (month precision)
Study completion2029-01estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

HypertensionObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

Endpoints (56)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
28
Other (unclassified)
11
Weight & body composition
6
Renal / kidney
4
Glycemic / diabetes
3
Heart failure
2
Patient-reported / QoL
2

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Body weight

Time frame:Baseline to week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body fat

Time frame:Baseline to week 24

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Waist:hip ratio

Time frame:Baseline to week 24

ratio, improvement

Secondary/protocol endpoint

Body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body fat

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

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Waist:hip ratio

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

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint/low confidence

Insulin

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

HbA1C

Time frame:Baseline to week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1C

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

2 endpoints
Secondary/protocol endpoint

N-terminal pro-B-type natriuretic peptide

Time frame:Baseline to week 24

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint

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)

NT-proBNP, change

change from baseline, improvement

Renal / kidney

4 endpoints
Secondary/protocol endpoint

Estimated glomerular filtration rate

Time frame:Baseline to week 24

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urine albumin:creatinine ratio

Time frame:Baseline to week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Estimated glomerular filtration rate

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urine albumin:creatinine ratio

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

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

28 endpoints
Primary/protocol endpoint

Ambulatory systolic blood pressure

Time frame:Baseline to week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Ambulatory diastolic blood pressure

Time frame:Baseline to week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Clinic systolic blood pressure

Time frame:Baseline to week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Clinic diastolic blood pressure

Time frame:Baseline to week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Clinic mean arterial pressure

Time frame:Baseline to week 24

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint

Unattended systolic blood pressure

Time frame:Baseline to week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Unattended diastolic blood pressure

Time frame:Baseline to week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Unattended mean arterial pressure

Time frame:Baseline to week 24

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Cardiac output

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Peripheral vascular resistance

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Pulse wave analysis / pulse wave velocity

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Heart rate variability

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Leptin

Time frame:Baseline to week 24

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Lipid profile

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Antihypertensive medications

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Ambulatory systolic blood pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Ambulatory diastolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Clinic systolic blood pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Clinic diastolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Clinic mean arterial pressure

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

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint

Unattended systolic blood pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Unattended diastolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Unattended mean arterial pressure

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

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Peripheral vascular resistance

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

change from baseline, improvement

Secondary/protocol endpoint

Pulse wave analysis / pulse wave velocity

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Heart rate variability

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

change from baseline, descriptive

Secondary/protocol endpoint

Lipid profile

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

change from baseline, improvement

Secondary/protocol endpoint

Number of antihypertensive medications

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

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Quality of life measures

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Quality of life measures

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

descriptive, improvement

Other (unclassified)

11 endpoints
Secondary/protocol endpoint/low confidence

Renin

Time frame:Baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Aldosterone

Time frame:Baseline to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Plasma metanephrines

Time frame:Baseline to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

24-hour urine sodium

Time frame:Baseline to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

24-hour urine aldosterone

Time frame:Baseline to week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Cardiac output

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Plasma renin

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Plasma aldosterone

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Plasma metanephrines

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

24-hour urine sodium

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

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

24-hour urine aldosterone

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

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.