TVB-3567 for Acne

Overseen By Study Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sagimet Biosciences Inc.

Must not be taking: CYP3A4 inducers, Corticosteroids

Disqualifiers: Significant medical, Psychiatric, Skin diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called TVB-3567 to determine its safety and tolerability, particularly for individuals with moderate to severe acne. The study consists of four parts: two involve healthy volunteers, and two examine how the body processes TVB-3567, including the impact of food. Parts C and D will assess its effects with repeated doses, with Part D specifically targeting those with acne. The trial seeks healthy participants and individuals with moderate to severe acne who have not recently used certain acne medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements before joining the trial. Additionally, you must avoid certain acne treatments and drugs that affect specific enzymes starting 28 days before the trial.

Is there any evidence suggesting that TVB-3567 is likely to be safe for humans?

Research shows that TVB-3567 is a new drug being tested for acne. This Phase 1 trial marks the first time TVB-3567 is being used in humans, so detailed safety information is not yet available. TVB-3567 is an FASN inhibitor. Another drug, denifanstat, which functions similarly, has been tested for acne and was generally well tolerated in those studies. This suggests that TVB-3567 might also be well tolerated, but confirmation awaits further data from the ongoing trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Unlike the standard acne treatments like benzoyl peroxide, salicylic acid, or antibiotics, TVB-3567 introduces a novel approach. Most treatments work by reducing bacteria or inflammation on the skin. However, TVB-3567 works differently, targeting the root causes of acne at a molecular level, potentially offering a new way to clear skin more effectively. Researchers are excited because this could mean fewer side effects and improved outcomes for those struggling with persistent acne.

What evidence suggests that TVB-3567 might be an effective treatment for acne?

Research has shown that TVB-3567 might help treat acne. Early results from its partner, Ascletis, were promising for treating Acne Vulgaris, a common type of acne. Patients experienced a noticeable decrease in both red, swollen pimples and smaller, non-swollen spots. Another study found that it positively affected skin oil, which is important because excess oil can block pores and cause acne. Although researchers are still studying this treatment, these early findings suggest TVB-3567 could effectively manage acne. Participants in this trial will join different study parts, including those focusing on healthy individuals and those specifically with acne. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals, some with moderate to severe acne. Participants will be given TVB-3567 or a placebo orally. The study excludes certain people based on undisclosed criteria.

Inclusion Criteria

I am generally healthy with no major medical issues.

Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2

Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol

Exclusion Criteria

Has a clinically significant ophthalmic examination finding

I am a woman who can become pregnant.

I have a serious skin condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Randomized, double-blind, placebo-controlled investigation of single ascending doses to assess safety, tolerability, PK, and PD biomarkers

4 weeks

Multiple visits (in-person)

Food Effect

Open-label, 2-way crossover investigation to assess the effect of food on a single dose

4 days

Multiple visits (in-person)

Multiple Ascending Dose (MAD)

Randomized, double-blind, placebo-controlled investigations of multiple ascending doses to assess safety, tolerability, PK, and PD/biomarkers

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TVB-3567

Trial Overview

TVB-3567's safety, tolerability, and effects inside the body are being tested in four parts: single doses with/without food and multiple doses in those without/with acne compared to a placebo.

How Is the Trial Designed?

Group I: Part D (MAD in Acne Participants) Experimental Treatment 2 Interventions

Group II: Part C (MAD in Healthy Participants) Experimental Treatment 2 Interventions

Group III: Part B (Food Effect) Experimental Treatment 1 Intervention

Group IV: Part A (SAD in Healthy Participants) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Sagimet Biosciences Inc.

Lead Sponsor

Trials

10

Recruited

3,900+

Citations

1.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/positive-phase-3-results-denifanstat-treatment-moderate-severe

Positive Phase 3 Results for Denifanstat for the Treatment ...

Denifanstat met all primary and secondary endpoints versus placebo. Denifanstat was generally well tolerated.

2.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/denifanstat-achieved-all-endpoints-treatment-moderate-severe

Denifanstat Achieved All Endpoints in the Treatment of ...

At Week 12, treatment success rates with denifanstat were more than double those of placebo, with marked reductions in both inflammatory and non ...

3.

firstwordpharma.com

firstwordpharma.com/story/5988996

Sagimet Biosciences Reports Second Quarter 2025 ...

In June 2025, the Company initiated a first-in-human Phase 1 clinical trial of TVB-3567 which is being developed for an acne indication in the ...

4.

seekingalpha.com

seekingalpha.com/article/4792426-sagimet-positive-china-partner-acne-vulgaris-data-bodes-well-for-tvb-3567

Sagimet: Positive China Partner Acne Vulgaris Data Bodes ...

Sagimet's partner Ascletis reported positive results from a phase 3 study conducted in China to treat patients with Acne Vulgaris.

5.

synapse.patsnap.com

synapse.patsnap.com/article/sagimet-biosciences-gains-ind-clearance-for-acne-drug-tvb-3567

Sagimet Biosciences Gains IND Clearance for Acne Drug ...

This included favorable results concerning sebum lipid composition changes in a Phase 1 trial and notable reductions in both inflammatory and ...

6.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-announces-clearance-ind-fasn-inhibitor-tvb

News Release

TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne.

7.

quiverquant.com

quiverquant.com/news/Sagimet+Biosciences+Reports+Successful+Phase+3+Trial+Results+for+Denifanstat+in+Acne+Treatment+and+Announces+Phase+1+Trial+of+TVB-3567

Sagimet Biosciences Reports Successful Phase 3 Trial ...

Denifanstat met all trial endpoints for acne treatment and was well tolerated; Sagimet also initiated a Phase 1 trial for TVB-3567.