Healthy ParticipantsPhase 1/2NCT07427680
Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
A Phase 1/2 study testing TGM-312-SC01 in people with Healthy Participants and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Tangram Therapeutics Plc at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- TGM-312-SC01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2026to Jun 2028
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years who are able to provide written informed consent.
- Medically suitable for study participation based on protocol-defined assessments.
- For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.
Who cannot join
- Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.
- Recent participation in another investigational study.
- Use of medications that are prohibited by the protocol.
- Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Pharmacology
London
Study Director, +44 (0) 20 7042 5800, info@richmondpharmacology.com
About this study
Official title: RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Read the detailed description
This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.
- Being tested
- TGM-312-SC01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGM-312-SC01Drug
TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
PlaceboDrug
Placebo administered by subcutaneous injection according to a protocol-defined regimen.
| Study group | Role | What they receive |
|---|---|---|
| TGM-312-SC01 | Experimental | Participants will receive study treatment according to the assigned intervention. Receives: Drug: TGM-312-SC01 |
| Placebo | Placebo comparator | Participants will receive study treatment according to the assigned intervention. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
Measured: From start of study drug administration through 16 weeks after the last study drug administration.
Secondary outcomes (4)
Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)
Maximum observed plasma concentration derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after the last study drug administration.
Area under the plasma concentration-time curve (AUC) of TGM-312-SC01 (ng·h/mL)
Area under the plasma concentration-time curve derived from plasma concentration-time data.
Measured: From start of study drug administration through 48 hours after the last study drug administration.
Change from baseline in target gene mRNA expression levels in tissue homogenate
Change from baseline in mRNA expression levels of the target gene in homogenised tissue samples following administration of TGM-312-SC01, expressed as relative change from baseline.
Measured: From start of study drug administration through 16 weeks after the last study drug administration.
Change from baseline in target protein levels in tissue homogenate
Change from baseline in protein levels of the target gene product in homogenised tissue samples following administration of TGM-312-SC01, expressed as concentration or relative change from baseline.
Measured: From start of study drug administration through 16 weeks after the last study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start3 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tangram Therapeutics Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Medical Representative, Study director, Tangram Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427680
- Sponsor's protocol ID
- TGM-312-001
- Status last verified
- May 2026
- First submitted
- 30 Jan 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be disseminated through publication
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH
- ClinicalTrials.gov ID
- NCT07427680
- Acronym / sponsor ID
- TGM-312-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Tangram Therapeutics PlcIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Feb 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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Detailed description
This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGM-312-SC01 | Experimental | Drug: TGM-312-SC01Participants will receive study treatment according to the assigned intervention. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive study treatment according to the assigned intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 70 years who are able to provide written informed consent.
- Medically suitable for study participation based on protocol-defined assessments.
- For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.
Key exclusion criteria (4 listed)
- Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.
- Recent participation in another investigational study.
- Use of medications that are prohibited by the protocol.
- Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
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 |
|---|---|---|
| TGM-312-SC01TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen. | Drug | TGM-312-SC01 |
| PlaceboPlacebo administered by subcutaneous injection according to a protocol-defined regimen. | Drug | Placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
Time frame: From start of study drug administration through 16 weeks after the last study drug administration.
4 secondary outcomes
Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)
Time frame: From start of study drug administration through 48 hours after the last study drug administration.
Area under the plasma concentration-time curve (AUC) of TGM-312-SC01 (ng·h/mL)
Time frame: From start of study drug administration through 48 hours after the last study drug administration.
Change from baseline in target gene mRNA expression levels in tissue homogenate
Time frame: From start of study drug administration through 16 weeks after the last study drug administration.
Change from baseline in target protein levels in tissue homogenate
Time frame: From start of study drug administration through 16 weeks after the last study drug administration.
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 May 2026.
- Individual participant dataSharing planned: No. Study results will be disseminated through publication
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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.
Sponsor Medical Representative study director
Tangram Therapeutics
1 site 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 TGM-312-SC01 in people with Healthy Participants and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Tangram Therapeutics Plc at 1 site in United Kingdom.
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: looking for participants now, as of the sponsor's last update on 19 May 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 United Kingdom. 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?
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 Sponsor Clinical Trials Office (+44 20 4558 3826, clinicaltrials@tangramtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events [Safety and tolerability] (time frame: From start of study drug administration through 16 weeks after the last study drug administration.). 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 May 2026.