HypertriglyceridemiaPhase 1/2NCT05896254
Study of MAR001 in Adults With Metabolic Dysfunction
A Phase 1/2 study testing MAR001 in people with Hypertriglyceridemia, run by Marea Therapeutics at 2 sites in Australia.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- MAR001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Jul 2023to 13 Dec 2024
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to provide informed consent and comply with the intervention
- Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
- Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L)
Who cannot join
- Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
- Pregnant or breastfeeding mothers
- Terminal illness with expected survival of less than 1 year
- Note: additional inclusion/exclusion criteria may apply, per protocol
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
- Conditions
- Hypertriglyceridemia
- Being tested
- MAR001, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAR001Drug
Subcutaneous injection
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MAR001 | Experimental | Subcutaneous injection Receives: Drug: MAR001 |
| Placebo | Placebo comparator | Subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MAR001
Incidence and frequency of treatment-emergent adverse events
Measured: 12 weeks
Secondary outcomes (1)
Effect of MAR001 on triglyceride metabolism
Change from baseline in triglyceride levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start22 Jul 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex DePaoli, Study director, Marea Tx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896254
- Sponsor's protocol ID
- MAR-102
- Status last verified
- Nov 2025
- First submitted
- 31 May 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cummings BB, Joing MP, Bouchard PR, Milton MN, Moesta PF, Ramanan V, Lane A, Hirman J, Trauger JW, Maratos-Flier E, Voznesensky A, Splawski I, Nimonkar AV, Flaherty MM, Yi BA, Meyers D, Huet F, Sahambi SK, Yates DP, Hom D, Hinder M, Basson CT, O'Donnell C, Siegelman ES, Garrett CE, Lehrer-Graiwer J, Juliano RA, Weiss EJ. Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies. Lancet. 2025 May 31;405(10493):1923-1934. doi: 10.1016/S0140-6736(25)00825-6. Epub 2025 May 15.
PubMed 40383129
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
- ClinicalTrials.gov ID
- NCT05896254
- Acronym / sponsor ID
- MAR-102
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Marea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 9 Jun 2023 (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 purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAR001 | Experimental | Drug: MAR001Subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to provide informed consent and comply with the intervention
- Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
- Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L)
Key exclusion criteria (4 listed)
- Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
- Pregnant or breastfeeding mothers
- Terminal illness with expected survival of less than 1 year
- Note: additional inclusion/exclusion criteria may apply, per protocol
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 |
|---|---|---|
| MAR001Subcutaneous injection | Drug | MAR001 |
| PlaceboSubcutaneous injection | Drug | Placebo |
Primary outcome
Safety and tolerability of MAR001
Time frame: 12 weeks
Incidence and frequency of treatment-emergent adverse events
1 secondary outcome
Effect of MAR001 on triglyceride metabolism
Time frame: 12 weeks
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 13 Nov 2025.
- Derived from this study: PubMed 40383129Cummings BB, Joing MP, Bouchard PR, Milton MN, Moesta PF, Ramanan V, Lane A, Hirman J, Trauger JW, Maratos-Flier E, Voznesensky A, Splawski I, Nimonkar AV, Flaherty MM, Yi BA, Meyers D, Huet F, Sahambi SK, Yates DP, Hom D, Hinder M, Basson CT, O'Donnell C, Siegelman ES, Garrett CE, Lehrer-Graiwer J, Juliano RA, Weiss EJ. Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies. Lancet. 2025 May 31;405(10493):1923-1934. doi: 10.1016/S0140-6736(25)00825-6. Epub 2025 May 15.
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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.
Alex DePaoli study director
Marea Tx
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MAR001 in people with Hypertriglyceridemia, run by Marea Therapeutics at 2 sites 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 3 inclusion and 4 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 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
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?
Safety and tolerability of MAR001 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05896254, which also lists 1 linked publication.
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 13 Nov 2025.