A Phase 2 interventional study of MAR001 and Placebo in Hypertriglyceridemia, sponsored by Marea Therapeutics. Recruiting at 55 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Marea Therapeutics · Phase 2, Interventional, and Treatment
Among 150 studies in Hypertriglyceridemia with a site in United States — 10 open to participants now, 16 under way, 4 of them phase 3. Hypertriglyceridemia · United States.
Among the 150 studies in Hypertriglyceridemia with a site in United States, this one is the 18th largest by planned enrollment of the 145 interventional ones, is one of 6 that started in 2025, is one of 45 in phase 2, reaches primary completion later than 11 of the 15 other live ones, and was the 145th registered.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 316 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →10 of the 150 studies in Hypertriglyceridemia with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 22 Hypertriglyceridemia studies recruiting now, 9 (41%) set no upper age limit and 12 (55%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →150 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 6 started in 2025.
Median enrollment 52 across the 145 interventional studies, 130 across the 3 observational. Of the 124 that completed or were terminated, 57 (46%) have results posted.
74 of 150 have an industry lead sponsor. The 10 most frequent:
Marea Therapeutics is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Marea Therapeutics has 3 studies filed under Hypertriglyceridemia — fewer than ten, so there is no comparison to draw.
9 of the studies in Hypertriglyceridemia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05681351Phase 3Ionis Pharmaceuticals, Inc.CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) | 2027-03 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT05464784MediciNovaMN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia | 2026-12-31 |
| NCT07269210Eli Lilly and CompanyA Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia | 2027-03 |
| NCT07491172CRISPR Therapeutics AGA Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias | 2027-06 |
Among the 150 studies in Hypertriglyceridemia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.
MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B).
In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study).
Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered.
Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.
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.
Exclusion Criteria:
Uncontrolled hypothyroidism
Part B only: recent history of active pancreatitis
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injection
Drug: MAR001 · Drug: Placebo
Subcutaneous Injection
Drug: MAR001 · Drug: Placebo
Subcutaneous Injection
Drug: MAR001 · Drug: Placebo
Subcutaneous Injection
Drug: MAR001 · Drug: Placebo
Subcutaneous Injection
Subcutaneous injection
Primary Endpoint
Percent change from baseline at Week 12 in fasting TG compared to placebo
Time frame: 12 weeks
Secondary Endpoint
Proportion of participants with Part A: baseline TG ≥150 mg/dL achieving TG \<150 mg/dL at Week 12 compared to placebo Part B: baseline TG ≥500 mg/dL achieving TG \<500 mg/dL at Week 12 compared to placebo
Time frame: 12 weeks
Secondary Endpoint
Percent change from baseline at Week 12 in fasting RC compared to placebo
Time frame: 12 weeks
Secondary Endpoint
Percent change from baseline at Week 16 in non-fasting TG compared to placebo
Time frame: 16 weeks
Secondary Endpoint
Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL
Time frame: 12 weeks
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Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Nov 2027, 29 months after the start.
Of 23 phase 2 interventional studies under Hypertriglyceridemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 29 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: MAR001
Marea Therapeutics