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ACI-19764

Phase 1

Obesity | Small molecule | Other |AC Immune SA|Trials Updated: Sep 2, 2026

ACI-19764 target and mechanism

Molecular targetNLRP3
Target classInflammasome
ModalitySmall molecule

Also known as ACI-19764 at dose A1, ACI-19764 at dose A2, ACI-19764 at dose A3, ACI-19764 at dose A4, ACI-19764 at dose A5, ACI-19764 at dose A6, ACI-19764 at dose B1, ACI-19764 at dose B2

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

ACI-19764 clinical trials

ACI-19764 · 1 trial · 3 indications

Phase 1 1
NCT07463196A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk FactorsHealthy Participants
RECRUITING114 Analytics
PHASE1RECRUITING
A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants and in Participants With Cardiovascular Risk Factors
Healthy Participants
NCT07463196114
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Study Endpoints

Primary Endpoints

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related)
From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C)
Vital signs: Change from baseline in blood pressure
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in respiratory rate
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in pulse rate
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in body temperature
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in heart rate
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in PR interval
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QRS interval
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QT interval
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcF interval
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcB interval
From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
From baseline up to the end of the treatment and observation period (i.e. Day 17 for study Part B and Day 28 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax), stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax), stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last)
From baseline to up to the end of the treatment and observation period (i.e. Day 4)

Applicable to study Part A only

Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity)
From baseline to up to the end of the treatment and observation period (i.e. Day 4)

Applicable to study Part A only

Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½)
From baseline to up to the end of the treatment and observation period (i.e. Day 4)

Applicable to study Part A only

Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity
From baseline to up to the end of the treatment and observation period (i.e. Day 4)

Applicable to study Part A only

Pharmacokinetic (PK) in plasma: AUCtau (AUC of one dosing interval) after first and last study treatment administration, stratified by sex
From baseline to up to the end of the treatment period (i.e. Day 15 for study Part B and Day 29 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) after last study treatment administration, stratified by sex
From baseline to up to the last timepoint measured (i.e. Day 19 for study Part B and 21 to 24 days after Day 29 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Average plasma concentration at steady state (Cavg,ss) during the last dosing interval, stratified by sex
From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Minimum plasma concentration at steady state (Cmin,ss) during the last dosing interval, stratified by sex
From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Trough (pre-dose) plasma concentrations (Ctrough), stratified by sex
From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in plasma: Accumulation index (AI) for Cmax and AUCtau, stratified by sex
From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)

Applicable to study Parts B and C only

Pharmacokinetic (PK) in CSF: Drug concentration at steady state (trough level capturing Cmin), stratified by sex
From baseline to Day 13

Applicable to study Part B2 and B3 only

Secondary Endpoints

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state
From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax) in fed state
From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last), in fed state
From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo for study Part A (SAD)PLACEBO_COMPARATORParticipants receive a single oral dose of placebo
ACI-19764 at dose A1 for study Part A (SAD)EXPERIMENTALParticipants receive a single oral dose A1 of ACI-19764
ACI-19764 at dose A2 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A2 of ACI-19764
ACI-19764 at dose A3 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A3 of ACI-19764
ACI-19764 at dose A4 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A4 of ACI-19764
ACI-19764 at dose A5 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A5 of ACI-19764
ACI-19764 at dose A6 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A6 of ACI-19764
Placebo for study Part B (MAD)PLACEBO_COMPARATORParticipants receive multiple oral doses of placebo
ACI-19764 at dose B1 for study Part B (MAD)EXPERIMENTALParticipants receive multiple oral doses B1 of ACI-19764
ACI-19764 at dose B2 for study Part B (MAD) (optional)EXPERIMENTALParticipants receive multiple oral doses B2 of ACI-19764
ACI-19764 at dose B3 for study Part B (MAD) (optional)EXPERIMENTALParticipants receive multiple oral doses B3 of ACI-19764
Placebo for study Part CPLACEBO_COMPARATORParticipants receive multiple oral doses of placebo
ACI-19764 at dose C1 for study Part CEXPERIMENTALParticipants receive multiple oral doses C1 of ACI-19764

Interventions

NameTypeDescription
PlaceboDRUGPlacebo capsules matching ACI-19764 capsules
ACI-19764 at dose A1DRUGACI-19764 capsules at dose A1
ACI-19764 at dose A2DRUGACI-19764 capsules at dose A2
ACI-19764 at dose A3DRUGACI-19764 capsules at dose A3
ACI-19764 at dose A4DRUGACI-19764 capsules at dose A4
ACI-19764 at dose A5DRUGACI-19764 capsules at dose A5
ACI-19764 at dose A6DRUGACI-19764 capsules at dose A6
ACI-19764 at dose B1DRUGACI-19764 capsules at dose B1
ACI-19764 at dose B2DRUGACI-19764 capsules at dose B2
ACI-19764 at dose B3DRUGACI-19764 capsules at dose B3
ACI-19764 at dose C1DRUGACI-19764 capsules at dose C1
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Signed informed consent in a language understandable to the participant prior to any study-mandated procedure. 2. Healthy male (Parts A and B) or female (Part B) aged between 18 and 65 years (inclusive) at screening or, male or female with cardiovascular risk factors between ...

Countries:Netherlands
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Competitive Landscape -Obesity 304 trials

Top 20 of 35 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN8PHASE3Elecoglipron, Lenbelintide, AZD6234, AZD9550, AZD1043
Eli Lilly and CompanyLLY46PHASE3Orforglipron, Tirzepatide, Retatrutide, Eloralintide, Mirikizumab
Amgen Inc.AMGN12PHASE3Maridebart cafraglutide
Novo Nordisk A/S Sponsored ADR Class BNVO71PHASE3Cagrilintide, Semaglutide, Liraglutide, CagriSema, NNC0487-0111
Pfizer Inc.PFE15PHASE3Berobenatide, PF-08653945, PF-08656795, PF-08642534
Regeneron Pharmaceuticals, Inc.REGN5PHASE3mibavademab, Trevogrumab, Garetosmab, Olatorepatide, REGN20934
Rhythm Pharmaceuticals, Inc.RYTM6PHASE3Setmelanotide, Bivamelagon, RM-718
Structure Therapeutics, Inc. Sponsored ADRGPCR4PHASE3Aleniglipron, ACCG-2671
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Kailera Therapeutics, Inc.KLRA5PHASE3Ribupatide (KAI-9531), KAI-7535
Hoffmann-La RocheRHHBY11PHASE3Enicepatide, Petrelintide, RO7204239, RO7795081
AbbVie, Inc.ABBV2PHASE2ABBV-295
PfizerMTSR3PHASE3MET097, MET233
Biohaven Ltd.BHVN1PHASE2Taldefgrobep Alfa
Skye Bioscience, Inc.SKYE1PHASE2Nimacimab
Palatin Technologies, Inc.PTN1PHASE2bremelanotide
Veru IncVERU1PHASE2Enobosarm
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-2232, ALN-6222
Arrowhead Pharmaceuticals, Inc.ARWR2PHASE1ARO-INHBE, ARO-ALK7
Gilead Sciences, Inc.GILD1PHASE1GS-4571
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Recent Changes (Last 90 Days)

MEDIUMSep 2, 2026NCT07463196Enrollment: 78 → 114
MEDIUMSep 2, 2026NCT07463196Enrollment: 78 → 114
MEDIUMSep 2, 2026NCT07463196Enrollment: 78 → 114

Frequently asked questions about ACI-19764

What is ACI-19764?

ACI-19764 is an investigational small molecule developed by AC Immune SA for obesity. It is being studied in a Phase 1 clinical trial that includes healthy participants and participants with cardiovascular risk factors, including obesity and type 2 diabetes mellitus. It has not been approved by the FDA and remains in clinical development.

What does ACI-19764 target?

ACI-19764 targets NLRP3, a component of the inflammasome. The inflammasome is a protein complex involved in inflammatory signaling. By targeting NLRP3, ACI-19764 is designed to act on this inflammasome pathway, which is the mechanism under investigation in its clinical program.

Who makes ACI-19764?

ACI-19764 is developed by AC Immune SA, a company listed under the ticker ACIU. AC Immune SA is running the Phase 1 study of ACI-19764, which is currently recruiting participants in the Netherlands.

What phase is ACI-19764 in?

ACI-19764 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial is currently recruiting, with no completed trials reported for this asset.

What clinical trials is ACI-19764 in?

ACI-19764 is being studied in one clinical trial, NCT07463196, titled a study investigating the safety, absorption, elimination, and the effect on the immune system of ACI-19764 in healthy participants and in participants with cardiovascular risk factors. The trial is Phase 1, recruiting, and plans to enroll 114 participants in the Netherlands.

Is ACI-19764 the same as ACI-19764 at dose A1 or ACI-19764 at dose A2?

Yes. ACI-19764 at dose A1, A2, A3, A4, A5, A6, B1, B2, B3, and C1 all refer to the same investigational drug, ACI-19764. These labels describe different dose cohorts within the same Phase 1 clinical program rather than separate drug candidates.

Other drugs targeting NLRP3

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