NCT07863193 · Sagimet Biosciences Inc.
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne
What this study is about
The purpose of this study is to evaluate the safety and effectiveness of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age.
View original scientific description
The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.
Interventions
DRUG
Denifanstat
Oral, once daily
OTHER
Placebo
Oral, once daily
Primary outcome measures
Proportion of participants achieving EGSS success, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from their baseline score
Time frame: Week 12
Absolute change from baseline in inflammatory lesion count (ILC)
Time frame: Week 12
Absolute change from baseline in non-inflammatory lesion count (ILC)
Time frame: Week 12
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must be willing and able to participate in the trial and provide written informed consent or assent
- Aged ≥12 years on the date that written informed consent/ assent is provided
- Moderate to severe acne vulgaris based on the following criteria at screening:
- The EGSS at screening of 3 or 4. AND
- Number of facial skin lesions:
- 30 to 75 inflammatory lesions
- 30 to 100 noninflammatory lesions
- All participants with their partners, if any, must agree to the use of an acceptable method of highly effective contraception. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding, must not plan to become pregnant during the study, and must use 2 forms of birth control, one being a barrier method, or be sexually abstinent.
Exclusion criteria
- Presence of \>2 facial cysts/ nodules
- Cystic acne, acne fulminans or acne conglobata
- Other significant skin diseases that may affect the efficacy evaluation or require co-treatment
- History of clinically significant dry eye, such as Ocular Surface Disease Index (OSDI) ≥33, or corneal staining ≥ grade III on Oxford Grading Scale, chronic dry eye, or other corneal abnormality
- Use of concomitant strong cytochrome P450 (CYP) 3A4 inducers and strong or moderate inhibitors within 2 weeks prior to Day 1 the trial except Paxlovid®
- Use of a glucagon-like-peptide 1 (GLP-1) agonist for \<12 weeks prior to first dose of trial medication
- Use of any of the following:
- Introduction of any drug known to prolong QT interval corrected for heart rate (QTC)
- Sensitive substrates of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP)
- Herbs and supplements such as St John's Wort or grapefruit juice.
- Use of concomitant acne treatments unless appropriate washout period is documented
Where
- Bryant, Arkansas
- Fremont, California
- Doral, Florida
- Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations