HypertriglyceridemiaPhase 2NCT07604974
A Study to Assess the Safety, Tolerability and Efficacy of ION775
A Phase 2 study testing ION775 in people with Hypertriglyceridemia and Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 17 sites in 2 countries.
Trial summary
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia, Severe Hypertriglyceridemia
- What is being tested?
- ION775
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 12 May 2026to Mar 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) [3.95 millimoles per liter (mmol/L)] or with sHTG (fasting TG ≥ 500 mg/dL [5.65 mmol/L]).
- Participants should be on standard of care lipid-lowering medications per local guidelines.
Who cannot join
- Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.
- Alanine aminotransferase or aspartate aminotransferase > 2.0 × upper limit of normal.
- Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome.
- Estimated GFR < 30 mL/min/1.73 m^2.
- Note: Other protocol pre-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 16 recruiting
- Recruiting
Ionis Investigative Site
Aurora, Colorado, 80045
- Recruiting
Ionis Investigative Site
Boca Raton, Florida, 33434
- Recruiting
Ionis Investigative Site
Carmel, Indiana, 46290
- Recruiting
Ionis Investigative Site
Columbus, Georgia, 31904
- Recruiting
Ionis Investigative Site
Flint, Michigan, 48504
- Recruiting
Ionis Investigative Site
Houston, Texas, 77040
- Recruiting
Ionis Investigative Site
Lampasas, Texas, 76550
- Recruiting
Ionis Investigative Site
Lincoln, California, 95648
- Recruiting
Ionis Investigative Site
Little River, South Carolina, 29566
- Recruiting
Ionis Investigative Site
Louisville, Kentucky, 40213
- Recruiting
Ionis Investigative Site
McKinney, Texas, 75071
- Recruiting
Ionis Investigative Site
Mesquite, Texas, 75071
- Recruiting
Ionis Investigative Site
Miami, Florida, 33184
- Recruiting
Ionis Investigative Site
Miramar, Florida, 33027
- Recruiting
Ionis Investigative Site
Munroe Falls, Ohio, 44262
- Recruiting
Ionis Investigative Site
San Antonio, Texas, 78209
About this study
Official title: A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
Read the detailed description
This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.
- Conditions
- Hypertriglyceridemia, Severe Hypertriglyceridemia
- Being tested
- ION775
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ION775Drug
ION775 will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| ION775: Cohort A | Experimental | Participants will be randomized to receive ION775 by subcutaneous (SC) injection. Receives: Drug: ION775 |
| ION775: Cohort B | Experimental | Participants will be randomized to receive ION775 by SC injection. Receives: Drug: ION775 |
| ION775: Cohort C | Experimental | Participants will be randomized to receive ION775 by SC injection. Receives: Drug: ION775 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Fasting Triglyceride (TG)
Measured: Baseline, Month 6
Secondary outcomes (6)
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 12 Months
Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations
Measured: Up to 12 Months
Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III)
Measured: Baseline, Month 6
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
Measured: Baseline, Month 6
Percent Change From Baseline in Remnant Cholesterol When Directly Measured
Measured: Baseline, Month 6
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start12 May 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604974
- Sponsor's protocol ID
- ION775-CS2
- Status last verified
- Oct 2026
- First submitted
- 18 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT07604974
- Acronym / sponsor ID
- ION775-CS2
- Conditions
- Hypertriglyceridemia, Severe Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 May 2026 (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.
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
Detailed description
This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ION775: Cohort A | Experimental | Drug: ION775Participants will be randomized to receive ION775 by subcutaneous (SC) injection. |
| ION775: Cohort B | Experimental | Drug: ION775Participants will be randomized to receive ION775 by SC injection. |
| ION775: Cohort C | Experimental | Drug: ION775Participants will be randomized to receive ION775 by SC injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) [3.95 millimoles per liter (mmol/L)] or with sHTG (fasting TG ≥ 500 mg/dL [5.65 mmol/L]).
- Participants should be on standard of care lipid-lowering medications per local guidelines.
Key exclusion criteria (5 listed)
- Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.
- Alanine aminotransferase or aspartate aminotransferase > 2.0 × upper limit of normal.
- Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome.
- Estimated GFR < 30 mL/min/1.73 m^2.
- Note: Other protocol pre-specified inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| ION775ION775 will be administered by SC injection. | Drug | ION775: Cohort A, ION775: Cohort B, ION775: Cohort C |
Primary outcome
Percent Change From Baseline in Fasting Triglyceride (TG)
Time frame: Baseline, Month 6
6 secondary outcomes
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 12 Months
Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations
Time frame: Up to 12 Months
Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III)
Time frame: Baseline, Month 6
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
Time frame: Baseline, Month 6
Percent Change From Baseline in Remnant Cholesterol When Directly Measured
Time frame: Baseline, Month 6
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Time frame: Baseline, Month 6
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes. Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
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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.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ION775 in people with Hypertriglyceridemia and Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 17 sites in 2 countries.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ionis Pharmaceuticals, Inc. (1-844-828-3770, IonisION775-CS2@clinicaltrialmedia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Fasting Triglyceride (TG) (time frame: Baseline, Month 6). 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 Oct 2026.