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RecruitingNCT07463196Updated Sep 2, 2026

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

A Phase 1 interventional study of Placebo and ACI-19764 at dose A1 in Healthy Participants, Obesity and Type 2 Diabetes Mellitus (T2DM), sponsored by AC Immune SA. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by AC Immune SA · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main purposes of this study are:

  • to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors
  • to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal)
  • to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system

The effects of ACI-19764 will be compared with the effects of a placebo. ACI-19764 is a brain-penetrant NLRP3 inhibitor.

The study consists of 3 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses) in healthy participants, and Part C (one multiple-dose level) in participants with cardiovascular risk factors. Participants in Part A will receive the study compound once, and participants in Part B and Part C will receive the study compound multiple times (daily over 14 and 28 days, respectively). Parts A and B will be divided into different groups of participants to test different doses of ACI-19764.

Read the detailed description

In study Part A (SAD part), up to 6 dose levels with 8 male participants in each are planned (6 participants on ACI-19764 and 2 on placebo). Each cohort has a screening period followed by admission to the site for administration of ACI-19764 or placebo. Participants remain onsite for observation for 3 days. Participants may need to return for additional visits for 2 days after discharge to check the blood levels of the drug. A safety follow up call is planned approximately 3 weeks after discharge. In one of the higher dose cohorts, the effect of food on drug levels in the blood will also be explored with an additional admission. There may be fewer than 6 cohorts.

In study Part B (MAD part), up to 3 dose levels with 10 participants (8 on active and 2 on placebo) in each are planned. Each dose level will be investigated in a separate cohort of 10 healthy male and female participants (with 4 participants of each sex on active treatment and 1 of each sex on placebo). Each cohort has a screening period followed by admission to the site for 17 days (14-day treatment and 3 days observation). Depending on the blood levels of the drug, participants may have to return to the site for additional blood tests for the 2 days following discharge. A safety phone call is planned approximately 3 weeks after discharge.

In study Part C, a single cohort of 36 participants (18 on active and 18 on placebo) with cardiovascular risk factors is planned, including males and females. After the screening period, ACI-19764 or placebo will be administered orally once daily for 4 weeks (i.e., from Day 1 up to and including Day 28). Study participants will be confined to the study site from Day -1 up to Day 2 and from Day 28 to Day 29. In between, they will return to the study site for ambulatory visits on Day 10 and Day 17. When not on site, participants will take ACI-19764 or placebo daily at home. Participants will return to the study site on Day 31 for an ambulatory visit for blood collection. Depending on the blood levels of the drug, participants may have to return to the site on Day 35 for additional blood tests. A safety phone call is planned approximately 3 weeks after discharge.

02

Conditions studied

  • Healthy Participants
  • Obesity
  • Type 2 Diabetes Mellitus (T2DM)

Keywords

  • Phase 1
  • Healthy Participants
  • SAD/MAD
  • NLRP3 inhibitor
  • Pharmacokinetics
  • Obesity
  • Diabetes
  • Cardiovascular risks
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 114 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AC Immune SA is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed 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 18 and 75 years (inclusive) (Part C).
  3. For Parts A and B: of 18.0 to 29.9 kg/m2 (inclusive) at screening.
  4. For Part C: Presence of either obesity (defined as a BMI of 30.0-42.0 kg/m2 inclusive) and/or existing diagnosis of well controlled type II diabetes (with >6.5% or 48 mmol/mol and ≤8.5% or 69 mmol/mol) (for participants with diabetes the BMI can range between 18.0-42.0 kg/m2 inclusive).
  5. For Part C: serum CRP >3.0 mg/L and \<10.0 mg/L at screening and reconfirmed prior first dosing.
  6. Ability to communicate well with the investigator, and to understand and comply with the study requirements.
  7. Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 45-90 mmHg, and pulse rate 40 to 100 beats per minute (bpm) (all inclusive), measured on either arm (same arm used for both screening and admission), after 5 min in the supine position at screening and admission. For Part C: SBP may be 90-160 mmHg, and DBP 45-100 mmHg (all inclusive).
  8. 12-lead safety : corrected for HR using Fridericia's formula (QTcF) \<450 ms for male participants and \<470 ms for female participants, QRS interval \<120 ms, PR interval \<220 ms, and HR 40 to 100 bpm (inclusive), and without abnormalities, measured after 5 min in the supine position at screening and admission.
  9. For Part C: Estimated (eGFR) >60 mL/min/1.73 m2

  10. Fertile male participants (defined as physiologically capable of conceiving a child according to the investigator's judgment) must agree to refrain from fathering a child and:

    • Be sexually abstinent with women of (WoCBP) or use condoms during sexual intercourse with WoCBP from (first) study treatment administration up to at least 90 days after (last) study treatment administration. Male participants must advise their WoCBP partners consistently to use a highly effective method of with a failure rate of \<1% per year.
    • Do not donate sperm from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
  11. Parts B and C only: Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission and a follicle-stimulating hormone (FSH) test must be performed at screening. WoCBP must agree to consistently and correctly use (from screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of \<1% per year, be sexually inactive, or have a vasectomized partner with a post-vasectomy semen analysis negative for sperm at least 6 months before screening. If a hormonal contraceptive is used, it must be initiated at least 1 month before the first study treatment administration and should be used in conjunction with barrier methods. WoCBP must agree to not donate eggs from screening until at least 30 days after the last study treatment administration.
  12. Parts B and C only: WoNCBP must be or have documented previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, uterine agenesis.

Exclusion criteria

Exclusion Criteria:

  1. Known to any of the ACI-19764 formulations.
  2. Known hypersensitivity or allergy to any therapeutic treatment (including non-steroidal anti-inflammatory drugs [NSAIDs], or nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 [NLRP3] inhibitors), vaccines, cosmetics, natural rubber or latex and/or food.
  3. Clinically relevant findings on the physical examination at screening or on Day -1.
  4. Clinically relevant findings in clinical laboratory tests
  5. Clinically relevant history or presence of rhythm disorders, congestive heart failure, or structural heart disease.
  6. History or presence of clinically relevant surgical intervention which, in the opinion of the investigator, could potentially interfere with the safety/tolerability and/or absorption, distribution, metabolism, and excretion (ADME) of the study treatment.
  7. History or presence of acute, ongoing, recurrent, or chronic clinically relevant diseases which, in the opinion of the investigator, could potentially interfere with the assessment of safety/tolerability and/or ADME of the study treatment. For Part C: obesity, well-controlled type 2 diabetes, well-controlled hypertension, hypercholesterolemia, and osteoarthritis are acceptable co-morbidities.
  8. For Part C: occurrence of diabetic ketoacidosis within the last 3 months
  9. History or current acute or chronic pulmonary pathology including but not limited to (COPD), asthma, and recurrent lung infections.
  10. Lifetime history of suicide attempt (including active attempt, interrupted attempt or aborted attempt) or suicidal ideation in the past 6 months according to the C-SSRS at screening (Parts B and C only).
  11. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma, and melanoma in situ, or in-situ prostate cancer, in-situ cervix carcinoma, or in-situ breast cancer which have been fully removed and are considered cured.
  12. Previous unexplained history of recurrent pre-syncope or syncope with no clear provoking features or syncope in the context of medical investigations that is likely to complicate interpretation of the safety of the drug in the opinion of the Investigator.
  13. Veins unsuitable for intravenous (i.v.) puncture on both arms.
  14. Participation in a clinical study involving study treatment administration within 3 months (or within 5 half-lives before screening, whichever is longer) prior to (the first) study treatment administration or in more than 3 clinical studies within 1 year prior to (the first) study treatment administration.
  15. History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
  16. Consumption of >14 units of alcohol per week (females) or >21 units per week (males).
  17. Excessive caffeine consumption.
  18. Nicotine consumption from 3 months prior to (first) study treatment administration, checked at screening and on Day -1.
  19. Loss (including donation) of 450 mL or more of blood or blood products within 2 months prior to (the first) study treatment administration.
  20. Positive results from serum/urine drug or alcohol screen test at screening or on Day -1.
  21. Positive and/or C serology results, except for vaccinated participants or those with past but resolved hepatitis, at screening.
  22. Positive (HIV) serology results at screening.
  23. Any circumstances or conditions which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
  24. Legal incapacity or limited legal capacity at screening.
  25. Treatment or intended treatment with any prescribed medications within 2 weeks prior to (first) study treatment administration, except for (including hormonal contraceptive devices) in female participants (Part B and C only), and/or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 1 week prior to (first) study treatment administration. Analgesia with paracetamol is acceptable (but not NSAIDs or aspirin >75 mg per day), unless for the short-term treatment of post lumbar puncture (LP) headache. For Part C: prescribed and OTC (including vitamins and minerals) are permitted (apart from exceptions listed below) provided they have been on a stable dose in the 3 months prior to screening.
  26. Any therapies within 2 months or 5 half-lives (whichever is longer) prior to first study treatment administration.
  27. Current or recent use (within 1 month or 5 half-lives whichever is longer) of glucagon-like peptide-1 (GLP1) receptor agonists.
  28. Any biological compound for research or medical reasons within 12 months prior to (first) study treatment administration.
  29. Any relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to screening and/or an ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at screening. If mild infections occur during screening causing a rise in C-reactive protein (CRP), that is ≥10.0 mg/L, the participant should not be included until this has normalized.
  30. Receipt of vaccine within 5 weeks prior to admission.
  31. Any medical history of an active tuberculosis (TB) infection, positive test result for latent TB in the last 2 years, or any contact with TB-positive individuals in the last 4 weeks prior to screening.
  32. Potential anticipated lack of compliance with study assessments and visit schedule.
  33. Planned hospitalization (other than for study assessments) or surgery during the study.
  34. Part A Food effect cohort only: Inability or unwillingness to completely consume the high-fat breakfast prior to study treatment administration.
  35. Parts B and C only: Pregnant or lactating women.
  36. Part B (for those undergoing LP): for LP including, but not limited to space-occupying lesions with mass effect or raised intracranial pressure, posterior fossa mass, anticoagulant or antiplatelet medications, coagulopathy, thrombocytopenia (\<150×109/L), congenital spine abnormality, skin infection at the LP site or tattoo covering puncture site.
  37. Part B (for those undergoing LP): Lower back pain at the time of the study or history of recurrent headaches in the last 6 months (more than 4 days a month of headaches that limit normal daily activity)
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
114 participants (estimated)

Study arms

  • Placebo comparator
    Placebo for study Part A (SAD)

    Participants receive a single oral dose of placebo

    Drug: Placebo

  • Experimental
    ACI-19764 at dose A1 for study Part A (SAD)

    Participants receive a single oral dose A1 of ACI-19764

    Drug: ACI-19764 at dose A1

  • Experimental
    ACI-19764 at dose A2 for study Part A (SAD) (optional)

    Participants receive a single oral dose A2 of ACI-19764

    Drug: ACI-19764 at dose A2

  • Experimental
    ACI-19764 at dose A3 for study Part A (SAD) (optional)

    Participants receive a single oral dose A3 of ACI-19764

    Drug: ACI-19764 at dose A3

  • Experimental
    ACI-19764 at dose A4 for study Part A (SAD) (optional)

    Participants receive a single oral dose A4 of ACI-19764

    Drug: ACI-19764 at dose A4

  • Experimental
    ACI-19764 at dose A5 for study Part A (SAD) (optional)

    Participants receive a single oral dose A5 of ACI-19764

    Drug: ACI-19764 at dose A5

  • Experimental
    ACI-19764 at dose A6 for study Part A (SAD) (optional)

    Participants receive a single oral dose A6 of ACI-19764

    Drug: ACI-19764 at dose A6

  • Placebo comparator
    Placebo for study Part B (MAD)

    Participants receive multiple oral doses of placebo

    Drug: Placebo

  • Experimental
    ACI-19764 at dose B1 for study Part B (MAD)

    Participants receive multiple oral doses B1 of ACI-19764

    Drug: ACI-19764 at dose B1

  • Experimental
    ACI-19764 at dose B2 for study Part B (MAD) (optional)

    Participants receive multiple oral doses B2 of ACI-19764

    Drug: ACI-19764 at dose B2

  • Experimental
    ACI-19764 at dose B3 for study Part B (MAD) (optional)

    Participants receive multiple oral doses B3 of ACI-19764

    Drug: ACI-19764 at dose B3

  • Placebo comparator
    Placebo for study Part C

    Participants receive multiple oral doses of placebo

    Drug: Placebo

  • Experimental
    ACI-19764 at dose C1 for study Part C

    Participants receive multiple oral doses C1 of ACI-19764

    Drug: ACI-19764 at dose C1

Interventions

  • DrugPlacebo

    Placebo capsules matching ACI-19764 capsules

  • DrugACI-19764 at dose A1

    ACI-19764 capsules at dose A1

  • DrugACI-19764 at dose A2

    ACI-19764 capsules at dose A2

  • DrugACI-19764 at dose A3

    ACI-19764 capsules at dose A3

  • DrugACI-19764 at dose A4

    ACI-19764 capsules at dose A4

  • DrugACI-19764 at dose A5

    ACI-19764 capsules at dose A5

  • DrugACI-19764 at dose A6

    ACI-19764 capsules at dose A6

  • DrugACI-19764 at dose B1

    ACI-19764 capsules at dose B1

  • DrugACI-19764 at dose B2

    ACI-19764 capsules at dose B2

  • DrugACI-19764 at dose B3

    ACI-19764 capsules at dose B3

  • DrugACI-19764 at dose C1

    ACI-19764 capsules at dose C1

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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)

  2. Vital signs: Change from baseline in blood pressure

    Time frame: 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)

  3. Vital signs: Change from baseline in respiratory rate

    Time frame: 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)

  4. Vital signs: Change from baseline in pulse rate

    Time frame: 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)

  5. Vital signs: Change from baseline in body temperature

    Time frame: 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)

  6. ECG: Change from baseline in heart rate

    Time frame: 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)

  7. ECG: Change from baseline in PR interval

    Time frame: 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)

  8. ECG: Change from baseline in QRS interval

    Time frame: 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)

  9. ECG: Change from baseline in QT interval

    Time frame: 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)

  10. ECG: Change from baseline in QTcF interval

    Time frame: 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)

  11. ECG: Change from baseline in QTcB interval

    Time frame: 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)

  12. Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)

    Applicable to study Parts B and C only

    Time frame: 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)

  13. Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax), stratified by sex

    Time frame: 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)

  14. Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax), stratified by sex

    Time frame: 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)

  15. 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)

    Applicable to study Part A only

    Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)

  16. Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity)

    Applicable to study Part A only

    Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)

  17. Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½)

    Applicable to study Part A only

    Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)

  18. Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity

    Applicable to study Part A only

    Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)

  19. Pharmacokinetic (PK) in plasma: AUCtau (AUC of one dosing interval) after first and last study treatment administration, stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  20. Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) after last study treatment administration, stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  21. Pharmacokinetic (PK) in plasma: Average plasma concentration at steady state (Cavg,ss) during the last dosing interval, stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  22. Pharmacokinetic (PK) in plasma: Minimum plasma concentration at steady state (Cmin,ss) during the last dosing interval, stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  23. Pharmacokinetic (PK) in plasma: Trough (pre-dose) plasma concentrations (Ctrough), stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  24. Pharmacokinetic (PK) in plasma: Accumulation index (AI) for Cmax and AUCtau, stratified by sex

    Applicable to study Parts B and C only

    Time frame: 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)

  25. Pharmacokinetic (PK) in CSF: Drug concentration at steady state (trough level capturing Cmin), stratified by sex

    Applicable to study Part B2 and B3 only

    Time frame: From baseline to Day 13

Secondary outcomes

  1. Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state

    Applicable to study Part A Food Effect group only

    Time frame: 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

  2. Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax) in fed state

    Applicable to study Part A Food Effect group only

    Time frame: 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

  3. 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

    Applicable to study Part A Food Effect group only

    Time frame: 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

  4. Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity) in fed state

    Applicable to study Part A Food Effect group only

    Time frame: 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

  5. Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) in fed state

    Applicable to study Part A Food Effect group only

    Time frame: 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

  6. Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity in fed state

    Applicable to study Part A Food Effect group only

    Time frame: 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

  7. Pharmacodynamic (PD) effect of ACI-19764 (target engagement [TE]) after SAD and MAD administration of ACI-19764 in healthy participants and of one multiple-dose level in participants with cardiovascular risk factors, stratified by sex

    Change from baseline in PD parameters. Given as % of target engagement in whole blood assay (i.e. Inhibition of IL-1β release after ex vivo LPS and ATP stimulation)

    Time frame: From baseline up to the last timepoint measured (i.e. Day 4 for study Part A, Day 19 for study Part B, and 21 to 24 days after Day 29 for study Part C)

  8. Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors

    Proportion of participants with serum C-reactive protein (CRP) \<2 mg/L after 4 weeks of treatment. Applicable to study Part C only

    Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

  9. Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors

    Proportion of participants with serum C-reactive protein (CRP) \<1 mg/L after 4 weeks of treatment. Applicable to study Part C only

    Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

  10. Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors

    Percentage change from baseline in serum C-reactive protein (CRP) after 4 weeks of treatment. Applicable to study Part C only

    Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

  11. Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors

    Absolute change from baseline in serum C-reactive protein (CRP) after 4 weeks of treatment. Applicable to study Part C only

    Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

07

Study locations

1 of 1 sites recruiting
  • ICON
    Groningen, 9728 NZ, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 11 months is above that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2026
First posted
Mar 11, 2026
StartActual
Jan 28, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463196
Lead sponsor
AC Immune SA
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Mar 11, 2026
Start date
Jan 28, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 2, 2026

Study contacts

AC Immune Clinical Lead
Contact
clinicaltrials@acimmune.com
+41213459121
Principal Investigator
principal investigator · ICON plc
Clinical Lead
study director · AC Immune SA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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