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

November 3, 2026 updated by: Sagimet Biosciences Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • Sagimet Investigative Site
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Sagimet Investigative Site
      • Fremont, California, United States, 94538
        • Recruiting
        • Sagimet Investigative Site
      • San Diego, California, United States, 92123
        • Recruiting
        • Sagimet Investigative Site
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Sagimet Investigative Site
    • Florida
      • Doral, Florida, United States, 33126
        • Recruiting
        • Sagimet Investigative Site
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Sagimet Investigative Site
      • Miami, Florida, United States, 33125
        • Recruiting
        • Sagimet Investigative Site
      • Miami, Florida, United States, 33126
        • Recruiting
        • Sagimet Investigative Site
      • Miami, Florida, United States, 33175
        • Recruiting
        • Sagimet Investigative Site
      • Miramar, Florida, United States, 33027
        • Recruiting
        • Sagimet Investigative Site
      • Sweetwater, Florida, United States, 33182
        • Recruiting
        • Sagimet Investigative Site
    • Illinois
      • Lincolnshire, Illinois, United States, 60069
        • Recruiting
        • Sagimet Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Sagimet Investigative Site
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Sagimet Investigative Site
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Sagimet Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Sagimet Investigative Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Sagimet Investigative Site
    • New Jersey
      • Robbinsville, New Jersey, United States, 08691
        • Recruiting
        • Sagimet Investigative Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28045
        • Recruiting
        • Sagimet Investigative Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Sagimet Investigative Site
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Sagimet Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Sagimet Investigative Site
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • Sagimet Investigative Site
      • Nashville, Tennessee, United States, 37215
        • Recruiting
        • Sagimet Investigative Site
    • Texas
      • College Station, Texas, United States, 77845
        • Recruiting
        • Sagimet Investigative Site
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Sagimet Investigative Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Sagimet Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must be willing and able to participate in the trial and provide written informed consent or assent

  2. Aged ≥12 years on the date that written informed consent/ assent is provided

  3. Moderate to severe acne vulgaris based on the following criteria at screening:

    1. The EGSS at screening of 3 or 4.

      AND

    2. Number of facial skin lesions:

      • 30 to 75 inflammatory lesions
      • 30 to 100 noninflammatory lesions

  4. 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:

  1. Presence of >2 facial cysts/ nodules

  2. Cystic acne, acne fulminans or acne conglobata

  3. Other significant skin diseases that may affect the efficacy evaluation or require co-treatment

  4. 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

  5. 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®

  6. Use of a glucagon-like-peptide 1 (GLP-1) agonist for <12 weeks prior to first dose of trial medication

  7. Use of any of the following:

    1. Introduction of any drug known to prolong QT interval corrected for heart rate (QTC)
    2. Sensitive substrates of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP)
    3. Herbs and supplements such as St John's Wort or grapefruit juice.

  8. Use of concomitant acne treatments unless appropriate washout period is documented

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo

Oral, once daily
Experimental: Denifanstat
Drug: Denifanstat

Oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 12
Absolute change from baseline in inflammatory lesion count (ILC)
Time Frame: Week 12
Week 12
Absolute change from baseline in non-inflammatory lesion count (ILC)
Time Frame: Week 12
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability (Open-Label Extension)
Time Frame: Week 52

Incidence of treatment-emergent adverse events and serious adverse events; change from baseline in safety parameters
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sagimet Biosciences Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

October 2, 2026

First Submitted That Met QC Criteria

October 2, 2026

First Posted (Actual)

October 7, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB2640-CLIN-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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