Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne

Part of paid clinical trials in Bryant, Arkansas.

Sponsor
Sagimet Biosciences Inc.
Study ID
NCT07863193
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acne Vulgaris

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Denifanstat — DRUG
    Oral, once daily
  • Placebo — OTHER
    Oral, once daily

Study Details

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.

Key Dates

First listed
Oct 7, 2026
Start date
Oct 31, 2026
Status verified
Oct 2026
Primary completion
Aug 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Denifanstat
  • Placebo Comparator: Placebo

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 ]

Central Contacts

  • Study Director
    (650) 561-8675

Locations (4)

FacilityCityStateZIPSite coordinators
Sagimet Investigative SiteBryantArkansas72022-
Sagimet Investigative SiteFremontCalifornia94538-
Sagimet Investigative SiteDoralFlorida33126-
Sagimet Investigative SiteMiamiFlorida33126-

Find similar trials in Bryant, AR

By research site
Sagimet Investigative Site· Bryant, ARSagimet Investigative Site· Fremont, CASagimet Investigative Site· Doral, FLSagimet Investigative Site· Miami, FL

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