Acne VulgarisPhase 3NCT07863193
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
A Phase 3 study testing Denifanstat in people with Acne Vulgaris, run by Sagimet Biosciences Inc. at 28 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Denifanstat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Oct 2026to Apr 2028
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 28 recruiting
- Recruiting
Sagimet Investigative Site
Beverly Hills, California, 90211
- Recruiting
Sagimet Investigative Site
Bryant, Arkansas, 72022
- Recruiting
Sagimet Investigative Site
Clinton Township, Michigan, 48038
- Recruiting
Sagimet Investigative Site
College Station, Texas, 77845
- Recruiting
Sagimet Investigative Site
Columbus, Ohio, 43215
- Recruiting
Sagimet Investigative Site
Doral, Florida, 33126
- Recruiting
Sagimet Investigative Site
East Greenwich, Rhode Island, 02818
- Recruiting
Sagimet Investigative Site
El Paso, Texas, 79902
- Recruiting
Sagimet Investigative Site
Fort Lauderdale, Florida, 33308
- Recruiting
Sagimet Investigative Site
Fremont, California, 94538
- Recruiting
Sagimet Investigative Site
Greenville, South Carolina, 29615
- Recruiting
Sagimet Investigative Site
Indianapolis, Indiana, 46250
- Recruiting
Sagimet Investigative Site
Lincolnshire, Illinois, 60069
- Recruiting
Sagimet Investigative Site
Miami, Florida, 33125
- Recruiting
Sagimet Investigative Site
Miami, Florida, 33126
- Recruiting
Sagimet Investigative Site
Miami, Florida, 33175
- Recruiting
Sagimet Investigative Site
Miramar, Florida, 33027
- Recruiting
Sagimet Investigative Site
Murfreesboro, Tennessee, 37130
- Recruiting
Sagimet Investigative Site
Nashville, Tennessee, 37215
- Recruiting
Sagimet Investigative Site
New Albany, Indiana, 47150
- Recruiting
Sagimet Investigative Site
Omaha, Nebraska, 68144
- Recruiting
Sagimet Investigative Site
Portsmouth, New Hampshire, 03801
- Recruiting
Sagimet Investigative Site
Robbinsville, New Jersey, 08691
- Recruiting
Sagimet Investigative Site
San Diego, California, 92123
- Recruiting
Sagimet Investigative Site
Santa Ana, California, 92705
- Recruiting
Sagimet Investigative Site
Spokane, Washington, 99202
- Recruiting
Sagimet Investigative Site
Sweetwater, Florida, 33182
- Recruiting
Sagimet Investigative Site
Wilmington, North Carolina, 28045
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design Trial to Evaluate the Safety and Efficacy of Denifanstat in Participants With Moderate to Severe Acne Vulgaris
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.
- Conditions
- Acne Vulgaris
- Being tested
- Denifanstat, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenifanstatDrug
Oral, once daily
PlaceboOther
Oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Denifanstat | Experimental | Not described Receives: Drug: Denifanstat |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Absolute change from baseline in inflammatory lesion count (ILC)
Measured: Week 12
Absolute change from baseline in non-inflammatory lesion count (ILC)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Oct 2026
- Primary completionAug 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863193
- Sponsor's protocol ID
- SB2640-CLIN-017
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design Trial to Evaluate the Safety and Efficacy of Denifanstat in Participants With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07863193
- Acronym / sponsor ID
- SB2640-CLIN-017
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denifanstat | Experimental | Drug: Denifanstat |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- AND
- 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.
Key exclusion criteria (11 listed)
- 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®
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 |
|---|---|---|
| DenifanstatOral, once daily | Drug | Denifanstat |
| PlaceboOral, once daily | Other | Placebo |
Primary outcome
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
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 5 Nov 2026.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
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.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denifanstat in people with Acne Vulgaris, run by Sagimet Biosciences Inc. at 28 sites in United States.
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 9 inclusion and 11 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Study Director ((650) 561-8675, clinicalhotline@sagimet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 5 Nov 2026.