Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity

NCT07241338 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025PHB414
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of sacubitril/Allisartan versus amlodipine in the antihypertensive treatment of overweight/obese patients with primary hypertension

Conditions

Hypertension

Keywords

obesity; overweight; hypertension; sacubitril/Allisartan

Outcome Measures

Primary Outcomes (1)

• The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine

  From the start of randomization to the end of treatment at 8 weeks

Secondary Outcomes (7)

• The change in the mean sitting diastolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine

  From the start of randomization to the end of treatment at 8 weeks

• The BP control rate of sacubitril/allisartan compared to amlodipine

  From the start of randomization to the end of treatment at 4 weeks and 8 weeks

• The BP response rate of sacubitril/allisartan compared to amlodipine

  From the start of randomization to the end of treatment at 8 weeks

• Changes in 24-hour mean ambulatory systolic and diastolic blood pressures of sacubitril/allisartan compared to amlodipine

  From the start of randomization to the end of treatment at 8 weeks

• Changes in daytime and night-time mean ambulatory blood pressures of sacubitril/allisartan compared to amlodipine

  From the start of randomization to the end of treatment at 8 weeks

Study Arms (2)

Sacubitril/Allisartan

EXPERIMENTAL

Drug: sacubitril/allisartan

Amlodipine

ACTIVE COMPARATOR

Drug: Amlodipine

Interventions

sacubitril/allisartan DRUG

Oral administration of sacubitril/allisartan 240mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of sacubitril/valsartan is increased to 480mg once daily for another 4 weeks of treatment

Also known as: angiotensin receptor neprilysin inhibitor, ARNI

Sacubitril/Allisartan

Amlodipine DRUG

Amlodipine group: Oral administration of amlodipine 5mg once daily for 4 consecutive weeks. If blood pressure reaches the target, the original regimen is continued; otherwise, the dose of amlodipine is increased to 10mg once daily for another 4 weeks of treatment

Also known as: calcium channel blocker, CCB

Amlodipine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years inclusive, regardless of gender;
• Body Mass Index (BMI) ≥ 24 kg/m²;
• Diagnosed with essential hypertension, either untreated or currently receiving antihypertensive medication;
• For patients who have not received antihypertensive medication in the past 3 months, the msSBP at the screening visit must be ≥ 150 mmHg and \< 180 mmHg;
• For patients currently receiving antihypertensive medication, the msSBP at the screening visit must be ≥ 140 mmHg and \< 180 mmHg; and at the visit after the washout period, the msSBP must be ≥ 150 mmHg and \< 180 mmHg.

You may not qualify if:

• Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, etc.;
• History of or diagnostic evidence for obstructive sleep apnea (OSA);
• History of angioedema;
• History of or diagnostic evidence for secondary hypertension;
• Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, or stroke occurring within 12 months; New York Heart Association (NYHA) Class II-IV heart failure, large aortic aneurysm or aortic dissection, atrioventricular block of degree II or higher, sick sinus syndrome, bradycardia (heart rate \< 50 beats per minute) or other arrhythmias requiring antiarrhythmic drugs, as well as severe diseases such as epilepsy and syncope;
• Clinically significant abnormalities in laboratory tests (serum potassium \> 5.5 mmol/L or \< 3.5 mmol/L; serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN); serum creatinine \> 1.5 × ULN);
• Type 1 diabetes mellitus and type 2 diabetes mellitus with poor glycemic control (glycated hemoglobin (HbA1c) \> 8.0%);
• Patients currently using drugs with weight-loss effects such as glucagon-like peptide-1 (GLP-1) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors;
• Patients undergoing hemodialysis or strict salt-restriction therapy;
• Known or suspected allergy to sacubitril/allisartan, sacubitril/valsartan sodium, amlodipine, or related drugs;
• Patients deemed unsuitable for participation in the study by the investigator.

Sponsors & Collaborators

• Jing Liu: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypertension; Obesity; Overweight

Interventions

sacubitril; Amlodipine; Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Study Officials

• Jing Liu, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu, MD

CONTACT

+8610 88325457; heartcenter@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Hypertension

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)