NCT06142383

Brief Summary

This was a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_2 heart-failure

Geographic Reach
12 countries

62 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

December 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 24, 2025

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

November 16, 2023

Results QC Date

October 30, 2025

Last Update Submit

January 7, 2026

Conditions

Heart Failure

Keywords

Heart failurerandomizeddouble-blinddose findingXXB750

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Ratio to Baseline in NT-proBNP at Week 16

    Summary statistics for observed NT-proBNP values are reported: Geometric mean ratio to baseline at week 16 is calculated by the geometric mean of the ratio of the week 16 value to the baseline value. Baseline is defined as the value at randomization visit.

    Baseline and week 16

Other Outcomes (1)

  • Baseline NT-proBNP Levels

    Baseline

Study Arms (5)

Arm 1

PLACEBO COMPARATOR

XXB750 Placebo

Biological: Placebo

Arm 2

EXPERIMENTAL

XXB750 60 mg

Biological: XXB750 Low dose

Arm 3

EXPERIMENTAL

XXB750 120 mg

Biological: XXB750 Medium Dose

Arm 4

EXPERIMENTAL

XXB750 240 mg

Biological: XXB750 High Dose

Arm 5

ACTIVE COMPARATOR

Sacubitril/valsartan, open label tablet, 97/103 mg bid (Sac/Val)

Drug: Sacubitril/valsartan

Interventions

XXB750 Medium DoseBIOLOGICAL

S.C. Injection

Arm 3
XXB750 High DoseBIOLOGICAL

S.C. Injection

Arm 4
Sacubitril/valsartanDRUG

Tablet

Arm 5
PlaceboBIOLOGICAL

S.C. Injection

Arm 1
XXB750 Low doseBIOLOGICAL

S.C. Injection

Arm 2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current symptom(s) of HF NYHA class II-III and LVEF \< 50%
  • Elevated NT-proBNP levels at screening.
  • Receiving standard of care background HF therapy.

You may not qualify if:

  • Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
  • Current symptomatic hypotension (for example dizziness/presyncope).
  • K+ \> 5.4 mmol/L at screening
  • eGFR \< 30 mL/min/1.73m2 at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (62)

SEC Clinical Research

Dothan, Alabama, 36305, United States

Location

Heart Center Research Llc

Huntsville, Alabama, 35801, United States

Location

Nature Coast Clinical Research LLC

Inverness, Florida, 34452, United States

Location

Inpatient Research Clinical LLC

Miami Lakes, Florida, 33014, United States

Location

Cardiology Partners Clinical Research Institute

Wellington, Florida, 33449, United States

Location

American Clinical Trials

Acworth, Georgia, 30101, United States

Location

The Research Group

Lexington, Kentucky, 40503, United States

Location

Heart Clinic of Hammond

Hammond, Louisiana, 70403, United States

Location

Anderson Medical Research

Ft. Washington, Maryland, 20744, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

NexGen Research

Lima, Ohio, 45801, United States

Location

Tennessee Center For Clinical Trials

Tullahoma, Tennessee, 37388, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Novartis Investigative Site

Blagoevgrad, 270 0, Bulgaria

Location

Novartis Investigative Site

Gabrovo, 5300, Bulgaria

Location

Novartis Investigative Site

Kyustendil, 2500, Bulgaria

Location

Novartis Investigative Site

Pleven, 5800, Bulgaria

Location

Novartis Investigative Site

Plovdiv, 4002, Bulgaria

Location

Novartis Investigative Site

Sofia, 1233, Bulgaria

Location

Novartis Investigative Site

Sofia, 1510, Bulgaria

Location

Novartis Investigative Site

Varna, 9010, Bulgaria

Location

Novartis Investigative Site

Xian, Shanxi, 710061, China

Location

Novartis Investigative Site

Berlin, 13347, Germany

Location

Novartis Investigative Site

Cologne, 51065, Germany

Location

Novartis Investigative Site

Gladbeck, 45968, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Ludwigshafen, 67067, Germany

Location

Novartis Investigative Site

Papenburg, 26871, Germany

Location

Novartis Investigative Site

Schwäbisch Hall, 74523, Germany

Location

Novartis Investigative Site

Budapest, Pest County, 1134, Hungary

Location

Novartis Investigative Site

Balatonfüred, 8230, Hungary

Location

Novartis Investigative Site

Belagavi, Karnataka, 590010, India

Location

Novartis Investigative Site

Bikaner, Rajasthan, 334003, India

Location

Novartis Investigative Site

Brescia, BS, 25123, Italy

Location

Novartis Investigative Site

Messina, ME, 98125, Italy

Location

Novartis Investigative Site

Milan, MI, 20138, Italy

Location

Novartis Investigative Site

Pordenone, PN, 33170, Italy

Location

Novartis Investigative Site

Roma, RM, 00133, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Trieste, TS, 34149, Italy

Location

Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 216-8511, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0375, Japan

Location

Novartis Investigative Site

Matsumoto, Nagano, 390-8621, Japan

Location

Novartis Investigative Site

Lisbon, 1449-005, Portugal

Location

Novartis Investigative Site

Vila Nova de Gaia, 4434 502, Portugal

Location

Novartis Investigative Site

Bardejov, Slovakia, 085 01, Slovakia

Location

Novartis Investigative Site

Košice, Slovakia, 040 01, Slovakia

Location

Novartis Investigative Site

Martin, Slovakia, 036 01, Slovakia

Location

Novartis Investigative Site

Nitra, Slovakia, 949 11, Slovakia

Location

Novartis Investigative Site

Prešov, Slovakia, 080 01, Slovakia

Location

Novartis Investigative Site

Svidník, Slovakia, 089 01, Slovakia

Location

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

Location

Novartis Investigative Site

Huelva, Andalusia, 21005, Spain

Location

Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

Location

Novartis Investigative Site

Las Palmas GC, 35010, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Málaga, 29010, Spain

Location

Novartis Investigative Site

Valencia, 46010, Spain

Location

Novartis Investigative Site

Valencia, 46026, Spain

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Related Publications (1)

  • Solomon SD, McMurray JJV, Felker GM, Januzzi JL, Lam CSP, Voors AA, Claggett B, Nuehrenberg TG, Rizkala AR, Koch C, Zhu W, Lefkowitz MP. The NPR1 agonist antibody XXB750 in heart failure: a phase 2 randomized trial. Nat Med. 2026 Mar 30. doi: 10.1038/s41591-026-04313-w. Online ahead of print.

    PMID: 41912806DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@Novartis.com
+ 1 862 778 8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patients received either active XXB750 injection or a placebo injection that looks identical to the active injection. Sacubitril/valsartan was administered in an open-label fashion
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

December 12, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

January 27, 2026

Results First Posted

December 24, 2025

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

CN(1)SL(6)TW(1)PT(2)IN(2)HU(2)ES(8)DE(7)IT(7)BU(8)JP(4)US(14)