Salubris completes Phase 3 sacubitril/allisartan trial in Chinese hypertension
The 376-patient trial finished on schedule against a blood-pressure endpoint, testing whether Salubris's triple-drug combination beats amlodipine alone in patients uncontrolled on amlodipine.
Executive Summary
- Salubris finished enrollment and reached its primary completion date on a Phase 3 trial testing its three-drug hypertension combination against amlodipine alone, with the blood-pressure result still pending disclosure.
- The combination's active ingredient, sacubitril, already anchors an approved heart-failure and hypertension therapy, so this trial's job is to show the triple-drug regimen reproduces that established blood-pressure effect in patients whose amlodipine monotherapy has failed.
- This is the second of two parallel Phase 3 trials Salubris is running for the same combination, one testing it against amlodipine and a companion trial testing it against the two-drug sacubitril/allisartan base, together mapping how the triple combination performs across step-up scenarios in uncontrolled hypertension.
- The trial enrolled to its full target, showed no protocol amendments, and completed close to its own guided date, indicating the operational story here is timing of disclosure, not execution risk.
The trial
NCT07704684 enrolled 376 patients in China with essential hypertension uncontrolled on amlodipine and randomized them to the triple combination of sacubitril, allisartan, and amlodipine or to amlodipine alone. The registered primary endpoint is the change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment. The trial reached its primary completion date of August 26, 2025 and moved to Completed status, with full study completion recorded September 8, 2025. No result has posted on ClinicalTrials.gov as of the current update. NCT07704684Assess Sacubitril/Allisartan and Amlodipine in Patients With Essential Hypertension Uncontrolled With AmlodipineNCT07704684
Program design
Salubris is running this trial alongside a nearly identical Phase 3 study, NCT07704697, which tests the same triple combination against the two-drug sacubitril/allisartan base rather than against amlodipine alone; that companion trial enrolled 346 patients and reached its own primary completion in November 2025. Together the two trials map the triple combination's blood-pressure effect against both of its component regimens, the design a sponsor uses to build a registrational data package spanning multiple add-on and step-up scenarios.
Mechanism and precedent
Sacubitril's neprilysin-inhibitor mechanism is already established in blood-pressure lowering: Novartis's LCZ696 combination (sacubitril/valsartan) met its primary endpoint against olmesartan in two prior Phase 3 trials in Asian and Japanese patients with essential hypertension, and against placebo in earlier Phase 2 studies. Sacubitril and its valsartan combination also carry multiple FDA-approved applications, including Novartis's Entresto and several generic sacubitril/valsartan approvals. This trial's job is to show the sacubitril/allisartan/amlodipine combination reproduces that blood-pressure-lowering effect when added on top of, or substituted for, amlodipine monotherapy, rather than to establish a new mechanism.
Competitive field
The essential-hypertension field carries no other Neprilysin-targeting trial active at the time of this trial's completion, and the four Neprilysin x Essential Hypertension trials on record, split between Novartis's earlier LCZ696 program and Salubris's current pair, have all completed without a termination. Salubris's own sponsor record shows a 100% completion rate across 13 prior trials. The trial carried no protocol amendments and enrolled to its full 376-patient target, which the trial's own registry history shows as a single, stable record from initiation to completion.
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