RESTORE-MASH A study to test if TGM-312-SC01 is safe in healthy people and people with MASH
Research type
Research Study
Full title
RESTORE-MASH: A First-in-human, Phase 1/2, Randomized, Masked, Placebo-Controlled, Parallel-Group, Dose-Escalation, Adaptive Study to Evaluate the Safety and Pharmacokinetics of a Single Dose of TGM-312-SC01 in Healthy Participants and the Safety, Pharmacokinetics, Pharmacodynamics and Early Signs of Efficacy of Multiple Doses of TGM-312-SC01 in People with Metabolic Dysfunction Associated Steatohepatitis (MASH)
IRAS ID
1012956
Contact name
Alison Shottek
Contact email
Sponsor organisation
Tangram Therapeutics plc
ISRCTN Number
ISRCTN65253349
Clinicaltrials.gov Identifier
Research summary
This trial will be completed in three parts and is being completed to test the trial drug called TGM-312-SC01 that has never been given to humans before and is administered via a sub-cut injection (an injection into a person’s fat tissue). The first part will be in healthy participants in the UK, with the first group testing a low dose of the trial drug given once, and if that dose is considered safe after a review of safety information such as blood pressure and blood test results, a slightly higher dose will tested in the second group and so on. This will continue up to a maximum of 6 groups if it is considered safe to do so. Each group will consists of 8 people, 2 of which will not receive the trial drug but will receive a placebo. After receiving the trial treatment, participants will have blood tests and perform procedures such as blood pressure readings to see what the drug does to the body and what the body does to the drug. From the information collected in the part with healthy people, a dose level will be selected to start the second part of the trial which will give the trial drug to people with MASH. The people with MASH that take part in the second part of the trial will receive the trial drug on two occasions and if safe to continue, two further groups will be recruited after the first group to test higher levels. It is planned that these groups in the second part of the study will have 9 people in each group and 3 people from each group will also receive placebo. After receiving the trial treatment, the participants will be perform some tests and procedures to check their health status and see what their body is doing to the drug. The third part of the study is optional and will also involve recruiting more participants with MASH to continue dosing as they did in the second part of the study, to get more information on the effects of the drug.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0352
Date of REC Opinion
30 Jan 2026
REC opinion
Further Information Favourable Opinion