Healthy Volunteers With HyperlipidemiaPhase 1NCT06452771
A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults
A Phase 1 study testing ALN-ANG3 in people with Healthy Volunteers With Hyperlipidemia, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
Trial summary
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides). The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers With Hyperlipidemia
- What is being tested?
- ALN-ANG3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteNew Zealand
- Study dates
- 27 Jun 2024to 4 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug
- Has fasting triglyceride (TG) levels >=100 and <500 mg/dL (1.13-5.65 mmol/L), defined as hyperlipidemia, and fasting Low-Density Lipoprotein (LDL-C) >=70 and <=300 mg/dL (1.81-7.76 mmol/L), defined as hyperlipidemia, during screening visit. Testing may be repeated once during the screening period in case the visit 1 levels fall outside of the required range
- Has a body mass index between 18 and 35 kg/m^2, inclusive, at screening visit
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological or other disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
- Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
- Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- With the exception of stable (approximately 3 months at same dose level) statin use, any prescription medication for approximately 2 weeks or 5 half-lives, whichever is longer, prior to first administration of the study drug through the End Of Study (EOS). Non-prescription medications and nutritional supplements are permitted after alignment of investigator and sponsor on their use
- Using the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology (CKD-EPI) equation, has an estimated Glomerular Filtration Rate (GFR) of <60 mL/min/1.73m2 at the screening visit, as defined in the protocol
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- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) with clinically significant abnormality in the opinion of investigator or ≥1.5× Upper Limit of Normal (ULN) range at screening or day -1 visits
- Is positive for Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) at the screening visit. Evidence of prior hepatitis B immunization or prior resolved hepatitis B infection is not an exclusion
- Is positive for hepatitis C antibody and positive for qualitative (ie, detected or not detected) Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit
- NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research
Christchurch, Canterbury, 8013
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides).
The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Read the detailed description
This is a 2-Part study. Participants in Part A are excluded from participation in Part B
- Conditions
- Healthy Volunteers With Hyperlipidemia
- Being tested
- ALN-ANG3, Placebo (PB)
- Keywords
- Elevated levels of blood lipids and cholesterol, Small interfering RNA (siRNA), Angiopoietin-like protein 3 (ANGPTL3), Liver cells protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-ANG3Drug
Administered per the protocol
Placebo (PB)Drug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohorts | Experimental | Not described Receives: Drug: ALN-ANG3; Drug: Placebo (PB) |
| Part B: Cohorts | Experimental | Not described Receives: Drug: ALN-ANG3; Drug: Placebo (PB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
In participants treated with ALN-ANG3 or placebo (PBO)
Measured: Up to Approximately 323 Days
Severity of TEAEs
In participants treated with ALN-ANG3 or PBO
Measured: Up to Approximately 323 Days
Secondary outcomes (2)
Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma
Part A
Measured: Within 3 Days Post Dose up to Approximately 323 Days
Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma
Part B
Measured: Prior to Each Dose up to Approximately 323 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start27 Jun 2024
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers With HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452771
- Sponsor's protocol ID
- ALN-ANG3-HV-2348
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06452771
- Acronym / sponsor ID
- ALN-ANG3-HV-2348
- Conditions
- Healthy Volunteers With Hyperlipidemia
- Keywords
- Elevated levels of blood lipids and cholesterol, Small interfering RNA (siRNA), Angiopoietin-like protein 3 (ANGPTL3), Liver cells protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Dec 2026 (estimated)
- First posted
- 11 Jun 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.
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides).
The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Detailed description
This is a 2-Part study. Participants in Part A are excluded from participation in Part B
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohorts | Experimental | Drug: ALN-ANG3, Drug: Placebo (PB) |
| Part B: Cohorts | Experimental | Drug: ALN-ANG3, Drug: Placebo (PB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug
- Has fasting triglyceride (TG) levels >=100 and <500 mg/dL (1.13-5.65 mmol/L), defined as hyperlipidemia, and fasting Low-Density Lipoprotein (LDL-C) >=70 and <=300 mg/dL (1.81-7.76 mmol/L), defined as hyperlipidemia, during screening visit. Testing may be repeated once during the screening period in case the visit 1 levels fall outside of the required range
- Has a body mass index between 18 and 35 kg/m^2, inclusive, at screening visit
Key exclusion criteria (10 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological or other disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
- Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
- Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- With the exception of stable (approximately 3 months at same dose level) statin use, any prescription medication for approximately 2 weeks or 5 half-lives, whichever is longer, prior to first administration of the study drug through the End Of Study (EOS). Non-prescription medications and nutritional supplements are permitted after alignment of investigator and sponsor on their use
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 |
|---|---|---|
| ALN-ANG3Administered per the protocol | Drug | Part A: Cohorts, Part B: Cohorts |
| Placebo (PB)Administered per the protocol | Drug | Part A: Cohorts, Part B: Cohorts |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Approximately 323 Days
In participants treated with ALN-ANG3 or placebo (PBO)
Severity of TEAEs
Time frame: Up to Approximately 323 Days
In participants treated with ALN-ANG3 or PBO
2 secondary outcomes
Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma
Time frame: Within 3 Days Post Dose up to Approximately 323 Days
Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma
Time frame: Prior to Each Dose up to Approximately 323 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 ALN-ANG3 in people with Healthy Volunteers With Hyperlipidemia, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. 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 New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
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 of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Approximately 323 Days). The study lists 2 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 20 Feb 2026.