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TGM-312-SC01

Phase 1

Healthy Participants | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: May 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

TGM-312-SC01 · 1 trial · 2 indications

Phase 1 1
NCT07427680Study of TGM-312-SC01 in Healthy Participants and Adults With MASHHealthy Participants
RECRUITING99 Analytics
PHASE1RECRUITING
Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
Healthy Participants
NCT0742768099
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Study Endpoints

Primary Endpoints

Incidence and severity of treatment-emergent adverse events [Safety and tolerability]
From start of study drug administration through 16 weeks after the last study drug administration.

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)
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)
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
From start of study drug administration through 16 weeks after the last study drug administration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TGM-312-SC01EXPERIMENTALParticipants will receive study treatment according to the assigned intervention.
PlaceboPLACEBO_COMPARATORParticipants will receive study treatment according to the assigned intervention.

Interventions

NameTypeDescription
TGM-312-SC01DRUGTGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
PlaceboDRUGPlacebo administered by subcutaneous injection according to a protocol-defined regimen.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 steat...

Countries:United Kingdom
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Frequently asked questions about TGM-312-SC01

What is TGM-312-SC01 used for?

TGM-312-SC01 is an investigational small molecule being studied in healthy participants and adults with metabolic dysfunction-associated steatohepatitis (MASH). It is in Phase 1 clinical development for metabolic conditions. The drug is not approved and remains under clinical investigation.

What does TGM-312-SC01 target?

TGM-312-SC01 is a small molecule in development for metabolic conditions. Its specific molecular target has not been disclosed. The drug is being studied in a Phase 1 trial for healthy participants and adults with MASH, metabolic dysfunction-associated steatohepatitis.

Who makes TGM-312-SC01?

TGM-312-SC01 is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is in Phase 1 clinical development for metabolic conditions, including MASH, metabolic dysfunction-associated steatohepatitis.

What phase is TGM-312-SC01 in?

TGM-312-SC01 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the drug in healthy individuals and adults with MASH.

What clinical trials is TGM-312-SC01 in?

TGM-312-SC01 is being studied in a Phase 1 clinical trial with the identifier NCT07427680. The trial, titled 'Study of TGM-312-SC01 in Healthy Participants and Adults With MASH,' is recruiting 99 participants in the United Kingdom. It is a randomized, double-blind, placebo-controlled study.

Is TGM-312-SC01 the same as any other drug?

TGM-312-SC01 is a unique investigational drug candidate developed by cbdMD, Inc. No alternative names have been reported for this compound. It is being studied under the clinical trial identifier NCT07427680 for metabolic conditions including MASH.