Coronary Heart DiseasePhase 1NCT06615284
A Study of Atorvo+™ in Healthy Adult Participants
A Phase 1 study testing Atorvo+™ (Arm1), Atorvo+™ +CBD (Arm 2) and Atorvo+™ +CBD (Arm 3) in people with Coronary Heart Disease and Dyslipidemias, run by Indication Bioscience LLC at 1 site in Australia.
Trial summary
A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants. . Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Dyslipidemias
- What is being tested?
- Atorvo+™ (Arm1), Atorvo+™ +CBD (Arm 2) and Atorvo+™ +CBD (Arm 3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jan 2025to 10 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for this study, a participant must meet all of the following inclusion criteria:
- Able to and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
- Male or female aged between 40 and 75 years (inclusive at the time of consent).
- Nonsmoker (not used any tobacco products within 2 months prior to Screening). Participants who smoke ≤ 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week can be included in the study at the discretion of the PI or designee if willing to abstain during inpatient stay.
- Body mass index (BMI) >18.0 and <32.0 kg/m2 at Screening and body weight ≥50.0 kg and ≤ 120.0 kg.
- Is judged by the Investigator to be in generally good health based on medical history, physical examination, vital sign parameters, ECG, laboratory parameters, and other relevant tests conducted at Screening.
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- Pulse between 50 and 100 beats per minute (bpm), inclusive at Screening.
- Systolic blood pressure (BP) between 100 and 140 mmHg, diastolic BP between 50 and 90 mmHg inclusive, at Screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
- No known allergic reaction to cannabis products (including tetrahydrocannabinol [THC], CBD, marijuana, and hashish) or EPIDIOLEX®.
- Must have hepatic and renal clinical laboratory test results (total bilirubin and estimated glomerular filtrate rate [eGFR] by the CKD-EPI [2021] equation) within a laboratory defined normal range at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designers.
- Females must not be pregnant, lactating, or planning pregnancy, and if they are a woman of childbearing potential (WOCBP), must use acceptable, highly effective contraception from Screening until 93 days (90 days + approximately 5 half-lives) after the last IP administration. Effective forms of contraception are defined in Section 7.2.2. Females with same-sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. Women of childbearing potential must have a negative serum hCG pregnancy test at Screening and negative urine test on Day -1. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle-stimulating hormone [FSH] levels ≥ 40 IU/L at Screening for amenorrhoeic female participants), or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- Male participants who are sexually active with WOCBP must meet any of the following criteria:
- Vasectomy for at least 6 months prior to enrolment and willing and able to use a condom.
- Willing and able to use one of highly effective contraception methods.
- Male participants with pregnant partners are not eligible.
- Male participants must be willing not to donate sperm throughout the study and for 93 days (90 days + approximately 5 half-lives) after the last dose of IP.
- Willing and able to adhere to all study requirements, including willingness to remain in the study unit for the entire duration of the confinement period.
- Participant has a good venous access bilaterally.
Who cannot join
- A participant who meets any of the following exclusion criteria must be excluded from the study:
- History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine (including type 2 diabetes), oncologic, pulmonary, immunologic, or cardiovascular disease or other condition which could jeopardize safety or impact validity of results at the discretion of the PI.
- Has any documented clinically significant infection, injury, or illness within 1 month prior to Screening.
- Has any documented history of, or currently active, seizure disorder or history of clinically significant head injury.
- Has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin).
- Any laboratory test results deemed clinically significant by the PI (clinically significant results may be repeated once at discretion of the investigator) or positive test for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
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- Positive COVID-19 polymerase chain reaction (PCR) test results at Day -1.
- History of inherent cardiac abnormalities at the discretion of the PI.
- Clinically significant ECG abnormalities (Fridericia's corrected QT interval [QTcF] >450 msec for males and >470 msec for females), PR >210 msec, QRS interval >120 msec at Screening (clinically significant results may be repeated once at discretion of the investigator).
- ALT, AST, total cholesterol, LDL-C, or triglycerides >1.5 × the upper limit of normal (ULN) at Screening. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or designees.
- Known allergic reactions to any excipient in the IP formulations.
- History of significant drug abuse such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to Screening.
- Use of marijuana or THC (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
- Positive screen for urine drug, urine cotinine (Day -1 only), or breath alcohol test at Screening or Day -1 (positive results may be repeated once at discretion of the investigator).
- History of significant alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months prior to Screening that exceeds 14 units of alcohol per week (1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of 40% distilled alcohol).
- Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or participant safety (eg, topical drug products without significant systemic absorption):
- Prescription medications (except for contraceptives) within 14 days prior to the first dose until end of the study;
- Monoamine oxidase inhibitors (MAOIs) within 28 days prior to dosing and during the study;
- Over-the-counter products and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines), and antacid preparations within 14 days prior to the first dose up to end of study. Vitamins used as nutritional supplements in non-therapeutic doses may be accepted at the discretion of the PI or designee, but they must be stopped at least 48 hours before dosing and during the study.
- Any drugs known to induce or inhibit hepatic and renal drug metabolism within 30 days prior to the first dose and during the study.
- Any known CYP2C9 and CYP3A4 enzymes altering drugs (eg, amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, etc.) within 28 days prior to the first dose and during the study.
- Any drug that has a significant impact on the central nervous system (CNS) including benzodiazepines (eg, diazepam, alprazolam, lorazepam), antipsychotic medications (eg, haloperidol, risperidone, quetiapine), antidepressants (eg, sertraline, fluoxetine, escitalopram), antiepileptic drugs (eg, phenytoin, carbamazepine, valproate) or sedative-hypnotics (eg, zolpidem, zopiclone, eszopiclone) within 30 days prior to the first dose and during the study.
- Any BP regularizing drugs including antihypertensive agents (eg, amlodipine, lisinopril, metoprolol), diuretics (eg, hydrochlorothiazide, furosemide, spironolactone), vasodilators (eg, hydralazine, nitroglycerin, minoxidil), alpha-blockers (eg, doxazosin, prazosin, terazosin) within 30 days prior to the first dose and during the study.
- Consumption of beverages or foods that contain grapefruit or Seville oranges, or products containing these fruits, within 7 days prior to the first dose and during the study.
- Use of any investigational or marketed drug or medical device in a clinical trial within 30 days of 5 half-lives (whichever is longer) prior to the first dose of IP administration, administration of a biological product in the context of a clinical research study within 90 days prior to IP administration, or concomitant participation in an investigational study involving no drug or device administration.
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 30 days prior to Day -1.
- Participant is unwilling to refrain from strenuous exercise (including weightlifting) from 7 days prior to admission to the site until completion of the final Follow-up visit.
- Any underlying physical or psychological medical condition that, in the opinion of the PI, could confound the results of the study or make it unlikely for the participant to comply with the protocol or complete the study per protocol.
- Current suicidal ideation as assessed by the C-SSRS (Baseline/Screening) up to 1 month prior to Screening; Participants with a significant psychiatric history including previous suicide attempt or a lifetime history of suicidal ideation may be excluded at the discretion of the PI or designee.
- Any reason which, in the opinion of the Investigator or Sponsor, would prevent the participant from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Single-Blind, Three-Arm, Staggered Parallel Study to Assess the Safety, Tolerability, and Pharmacokinetics of Atorvo+™ in Healthy Adult Participants
A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants.
.
Read the detailed description
This study will be testing an approved dose of atorvastatin (40 mg) and doses of CBD in the approved range (100 mg and 200 mg, approximately 1.7 mg/kg/day and 3.3 mg/kg/day for a 60 kg patient, respectively) in the study.
A total of 24 participants are planned to be enrolled into 3 study arms. Eight (8) participants are planned to be randomized in each of Arms 1, 2, and 3. Each arm will consist of a 28-days Screening period, a 28-day treatment period, and a 14-day follow-up period. Investigational products (IPs) refer to all study treatments and will be administered at the following planned dose levels:
- Arm 1: Atorvastatin (generic formulation) oral tablet 40 mg once daily for 28 days.
- Arm 2: Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) once daily for 28 days.
- Arm 3: Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) once daily for 28 days.
- Conditions
- Coronary Heart Disease, Dyslipidemias
- Being tested
- Atorvo+™ (Arm1), Atorvo+™ +CBD (Arm 2), Atorvo+™ +CBD (Arm 3)
- Keywords
- Atorvastatin, Cannabidiol, CBD, CHD, LDL-C
- Medical subject headings
- Coronary Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvo+™ (Arm1)Drug
Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).
Atorvo+™ +CBD (Arm 2)Drug
Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).
Atorvo+™ +CBD (Arm 3)Drug
Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Drug- Atorvastatin 40mg Dosage form- Oral tablet Frequency and duration- once daily for 28 days Receives: Drug: Atorvo+™ (Arm1) |
| Arm 2 | Experimental | Drug- Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days Receives: Drug: Atorvo+™ +CBD (Arm 2) |
| Arm 3 | Experimental | Drug- Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days Receives: Drug: Atorvo+™ +CBD (Arm 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and relationship of adverse events (AEs)
Measured: Baseline to End of study (Day 42) from first IP dose
Incidence of serious adverse events (SAEs)
Measured: Baseline to End of study (Day 42) from first IP dose
Incidence of adverse events of special interest (AESIs)
This includes clinically significant abnormal values in liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin), myopathy, myositis, myalgia, and type 2 diabetes
Measured: Baseline to End of study (Day 42) from first IP dose
Number of participants with changes in laboratory parameters
hematology, biochemistry, coagulation, and urinalysis), physical examination, vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR], and body temperature), electrocardiogram (ECG) parameters.
Measured: Baseline to End of study (Day 42) from first IP dose
Secondary outcomes (12)
Changes in Columbia-Suicide Severity Rating Scale (C-SSRS score)
Measured: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Maximum Plasma concentration (Cmax)
Measured: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Time for maximum concentration (Tmax)
Measured: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Area under Curve
Area under curve to the last measurable concentration (AUC0-t), Area under the curve of concentration versus time from zero to infinity (AUC0-∞) and %AUC extra will be assessed.
Measured: Baseline to End of study (Day 42) from first IP dose
PK parameters-Elimination rate constant (Kel)
Measured: Baseline to End of study (Day 42) from first IP dose
PK parameters- Half-life (t½)
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Basal respiration
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- ATP production.
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Proton leak
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Maximal respiration.
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed- Reserve capacity.
Measured: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
This is measured by mean change in oxygen consumption rate (OCR) in Atorvo+ ™ vs atorvastatin (Baseline to EOS visit). Key parameters to be assessed-Non-mitochondrial respiration.
Measured: Baseline to End of study (Day 42) from first IP dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start28 Jan 2025
- Primary completion14 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indication Bioscience LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James E Smeeding, Study chair, President, Indication Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615284
- Sponsor's protocol ID
- IB.ATO-875
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single-Blind, Three-Arm, Staggered Parallel Study to Assess the Safety, Tolerability, and Pharmacokinetics of Atorvo+™ in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06615284
- Acronym / sponsor ID
- IB.ATO-875
- Conditions
- Coronary Heart Disease, Dyslipidemias
- Keywords
- Atorvastatin, Cannabidiol, CBD, CHD, LDL-C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indication Bioscience LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants.
.
Detailed description
This study will be testing an approved dose of atorvastatin (40 mg) and doses of CBD in the approved range (100 mg and 200 mg, approximately 1.7 mg/kg/day and 3.3 mg/kg/day for a 60 kg patient, respectively) in the study.
A total of 24 participants are planned to be enrolled into 3 study arms. Eight (8) participants are planned to be randomized in each of Arms 1, 2, and 3. Each arm will consist of a 28-days Screening period, a 28-day treatment period, and a 14-day follow-up period. Investigational products (IPs) refer to all study treatments and will be administered at the following planned dose levels:
- Arm 1: Atorvastatin (generic formulation) oral tablet 40 mg once daily for 28 days.
- Arm 2: Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) once daily for 28 days.
- Arm 3: Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) once daily for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Atorvo+™ (Arm1)Drug- Atorvastatin 40mg Dosage form- Oral tablet Frequency and duration- once daily for 28 days |
| Arm 2 | Experimental | Drug: Atorvo+™ +CBD (Arm 2)Drug- Atorvo+™ Low (40 mg Atorvastatin and 100 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days |
| Arm 3 | Experimental | Drug: Atorvo+™ +CBD (Arm 3)Drug- Atorvo+™ High (40 mg Atorvastatin and 200 mg CBD) Dosage form- Oral tablet Frequency and duration- once daily for 28 days |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- To be eligible for this study, a participant must meet all of the following inclusion criteria:
- Able to and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
- Male or female aged between 40 and 75 years (inclusive at the time of consent).
- Nonsmoker (not used any tobacco products within 2 months prior to Screening). Participants who smoke ≤ 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week can be included in the study at the discretion of the PI or designee if willing to abstain during inpatient stay.
- Body mass index (BMI) >18.0 and <32.0 kg/m2 at Screening and body weight ≥50.0 kg and ≤ 120.0 kg.
Key exclusion criteria (30 listed)
- A participant who meets any of the following exclusion criteria must be excluded from the study:
- History of any clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine (including type 2 diabetes), oncologic, pulmonary, immunologic, or cardiovascular disease or other condition which could jeopardize safety or impact validity of results at the discretion of the PI.
- Has any documented clinically significant infection, injury, or illness within 1 month prior to Screening.
- Has any documented history of, or currently active, seizure disorder or history of clinically significant head injury.
- Has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvo+™ (Arm1)Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD). | Drug | Arm 1 |
| Atorvo+™ +CBD (Arm 2)Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD). | Drug | Arm 2 |
| Atorvo+™ +CBD (Arm 3)Atorvo+™ is a combination product containing atorvastatin and cannabidiol (CBD). | Drug | Arm 3 |
Primary outcome
Incidence, severity, and relationship of adverse events (AEs)
Time frame: Baseline to End of study (Day 42) from first IP dose
Incidence of serious adverse events (SAEs)
Time frame: Baseline to End of study (Day 42) from first IP dose
Incidence of adverse events of special interest (AESIs)
Time frame: Baseline to End of study (Day 42) from first IP dose
This includes clinically significant abnormal values in liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin), myopathy, myositis, myalgia, and type 2 diabetes
Number of participants with changes in laboratory parameters
Time frame: Baseline to End of study (Day 42) from first IP dose
hematology, biochemistry, coagulation, and urinalysis), physical examination, vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR], and body temperature), electrocardiogram (ECG) parameters.
12 secondary outcomes
Changes in Columbia-Suicide Severity Rating Scale (C-SSRS score)
Time frame: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Maximum Plasma concentration (Cmax)
Time frame: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Time for maximum concentration (Tmax)
Time frame: Baseline to End of study (Day 42) from first IP dose
PK Parameters- Area under Curve
Time frame: Baseline to End of study (Day 42) from first IP dose
PK parameters-Elimination rate constant (Kel)
Time frame: Baseline to End of study (Day 42) from first IP dose
PK parameters- Half-life (t½)
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
To evaluate mitochondrial oxidative stress in Atorvo+™ vs atorvastatin.
Time frame: Baseline to End of study (Day 42) from first IP dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Smeeding study chair
President, Indication Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvo+™ (Arm1), Atorvo+™ +CBD (Arm 2) and Atorvo+™ +CBD (Arm 3) in people with Coronary Heart Disease and Dyslipidemias, run by Indication Bioscience LLC at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and relationship of adverse events (AEs) (time frame: Baseline to End of study (Day 42) from first IP dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.