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New gout drug ABP-671 shows promise in lowering uric acid

NCT ID NCT05818085

Disease control Sponsor: Atom Therapeutics Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, ABP-671, for people with gout. Gout causes painful joint swelling due to high uric acid levels. The trial involved 300 adults and compared different doses of ABP-671 to a placebo and an older drug called allopurinol. The main goal was to see if ABP-671 could safely lower uric acid below a target level.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

300 people

The number who actually took part.

Started

Aug 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants aged ≥19 and \<70 years of age at the time of informed consent. * A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2. * Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows: * At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT. * At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L). * At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L). * Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug. Double contraception is defined as a condom AND one other form of the following: * Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones); * A vaginal ring or an intrauterine device OR * Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is the sole partner). The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant. Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing. -Men must be surgically sterile (\>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug. Exclusion Criteria: * History of rheumatoid arthritis or other autoimmune disease. * Clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder. * Positive test result for HIV, hepatitis B surface antigen, or hepatitis C virus antibody. Active hepatitis C virus infection is defined as a participant with a positive hepatitis C antibody and detectable hepatitis C viral load RNA. * Participants who, in the opinion of the Investigator, have a high genetic risk of allopurinol hypersensitivity syndrome unless they have been found to be negative for Human leukocyte antigen (HLA)-B\*5801, either clinically by prior exposure to allopurinol or by laboratory evaluation. * Liver function tests \>2x the laboratory upper limit of normal (ULN) range of aspartate aminotransferase, alkaline phosphatase, or alanine aminotransferase; total bilirubin \>1.5x ULN at Screening. * Inadequate renal function with serum creatinine \>1.5 mg/dL (\>0.133 mmol/L) or estimated glomerular filtration rate (eGFR) \< 60 mL/min/m2 (by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-based eGFR equation). * History of malignancy within the previous 5 years; with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer. * History within the last 12 months of unstable angina, New York Heart Association functional class III or IV heart failure, myocardial infarction, stroke, venous thromboembolism, or a history of percutaneous coronary intervention. * Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥90 mmHg). If BP is controlled while taking antihypertensive medication, the participant must be on stable dose for previous 2 months. * Active liver disease or impaired hepatic function as assessed by liver function tests. * Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening. * Any other medical or psychological condition, that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the study, or potentially compromise the results or interpretation of the study. * Pregnant, breastfeeding, or planning a pregnancy during the study or ≤30 days after the last dose of the study drug. * Intolerant or unwilling to take colchicine or naproxen.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout

Contacts and locations

Locations

  • A & D Doctor Center

    Miami, Florida, 33135, United States

  • A R Houston Medical Pty Ltd

    Kippa-Ring, Queensland, 4021, Australia

  • AMR

    New Orleans, Louisiana, 70119, United States

  • Academician Vakhtang Bochorishvili Clinic

    Tbilisi, 0186, Georgia

  • Accel Clinical Research Site

    DeLand, Florida, 32720, United States

  • Accel Research Sites Network - St. Pete-Largo Clinical Research Unit

    Largo, Florida, 33777, United States

  • Access Research Institute

    Brooksville, Florida, 34613, United States

  • Advanced Clinical Research of Atlanta

    Atlanta, Georgia, 30309, United States

  • Alliance for Multispecialty Research

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC.

    Newton, Kansas, 67114, United States

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Anaheim Clinical Trials (Cenexel ACT)

    Anaheim, California, 92801, United States

  • Annapolis Internal Medicine/CCT Research

    Annapolis, Maryland, 21401, United States

  • Austin Health - Repatriation Hospital

    Heidelberg, Victoria, 3084, Australia

  • Aversi Clini

    Tbilisi, 0160, Georgia

  • Bioclinical Research Alliance

    Miami, Florida, 33155, United States

  • Buddhist Dalin Tzu Chi General Hospital

    Chiayi City, 62247, Taiwan

  • Center for Clinical Trials of Sacramento

    Sacramento, California, 95823, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Centricity Research

    Suffolk, Virginia, 23435, United States

  • Century Research LLC

    Miami, Florida, 33173, United States

  • Chang Gung Memorial Hospital CGMH

    Kaohsiung City, 833, Taiwan

  • Chang Gung Memorial Hospital LinKou

    Taoyuan, 333423, Taiwan

  • Cheng-Shin General Hospital

    Taipei, 112401, Taiwan

  • Chung Shan Medical Univ. Hospital

    Taichung, 402367, Taiwan

  • ClinSearch

    Chattanooga, Tennessee, 37421, United States

  • Clinical Research Center (CRC)

    Guatemala City, 01010, Guatemala

  • Clínica Médica Especializada en Medicina Interna

    Guatemala City, 01010, Guatemala

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    Guatemala City, 01010, Guatemala

  • Clínica Médica Especializada en Medicina Interna y Reumatología

    Guatemala City, 1011, Guatemala

  • Clínica Médica Especializada en Medicina Interna y Reumatología (CREER)

    Guatemala City, 01010, Guatemala

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807, United States

  • Cordova Research Institute

    Miami, Florida, 33155, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research

    Tulsa, Oklahoma, 74133, United States

  • DelRicht Research of Gulfport

    Gulfport, Mississippi, 39501, United States

  • Emeritus Research Melbourne

    Camberwell, Victoria, 3124, Australia

  • Emeritus Research Sydney

    Botany, New South Wales, 2019, Australia

  • Evex Hospitals Caraps Medline

    Tbilisi, 0159, Georgia

  • ITB Research

    Miami, Florida, 33173, United States

  • Innova

    Tbilisi, 0186, Georgia

  • Inspire Santa Fe Medical Group

    Santa Fe, New Mexico, 87505, United States

  • JY Research Institute Inc.

    Cutler Bay, Florida, 33189, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • Medical Care/CCT

    Elizabethton, Tennessee, 37643, United States

  • Nature Coast Clinical Reasearch

    Crystal River, Florida, 34429, United States

  • New Horizons Research

    Palmetto Bay, Florida, 33158, United States

  • New Hospitals

    Tbilisi, 0114, Georgia

  • OnSite Clinical Solutions

    Salisbury, North Carolina, 28144, United States

  • PanAmerican Clinical Research, LLC

    Brownsville, Texas, 78520, United States

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales, 2259, Australia

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148, Australia

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114, United States

  • Quality Research Inc.

    San Antonio, Texas, 78209, United States

  • Santa Rosa Medical Center

    Las Vegas, Nevada, 89119, United States

  • The First Medical Center

    Tbilisi, 0180, Georgia

  • Tucson Neuroscience Research, LLC

    Tuscon, Arizona, 85710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.