RecruitingPhase 2Phase 3NCT07159841

A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)

A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension

Sponsor

Crinetics Pharmaceuticals Inc.

Enrollment

153 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia

Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).

Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atumelnant and a drug called Placebo for people with classic congenital adrenal hyperplasia and congenital adrenal hyperplasia. The study is currently recruiting participants at 33 locations. People eligible for this study include aged 1 Year to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtumelnant

Atumelnant, tablets, once daily by mouth, weight-based dosing

DRUGPlacebo

Placebo, tablets, once daily by mouth, weight-based dosing

Locations(43)

UCSF Ron Conway Gateway Medical Building

San Francisco, California, United States

Boston's Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai-Mount Sinai Hospital

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Instituto de Investigaciones Metabólicas

Buenos Aires, Buenos Aires, Argentina

Hospital de Niños de la Santísima Trinidad

Córdoba, Córdoba Province, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Instituto Médico Especializado (IME)

Buenos Aires, Argentina

CEDIE "Centro de Investigaciones Endocrinológicas", CONICET-FEI División de Endocrinología, Hosp de Niños Ricardo Gutiérrez

Buenos Aires, Argentina

Institute of Endocrinology of Diabetes, The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Monash Children's Hospital, Monash Health

Clayton, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

UZA (Antwerp University Hospital)

Edegem, Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

UZ Gent (University Hospital Ghent)

Ghent, East Flanders, Belgium

UZ Leuven (Universitair Ziekenhuis Leuven)

Leuven, Flemish Brabant, Belgium

Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)

São Paulo, São Paulo, Brazil

Centre Hospitalier Universitaire (CHU) d'Angers

Angers, France

Hopital Kremlin-Bicétre - APHP Paris Saclay

Le Kremlin-Bicêtre, France

Hopital Jeanne de Flandre - CHU de Lille

Lille, France

APHM -Hopital La Timone Enfants

Marseille, France

Hopital Necker - Enfants Malades

Paris, France

Hopital Robert Debre

Paris, France

Universitätsklinikum Tübingen Klinik fur Kinder und Jugendmedizin

Tübingen, Baden, Germany

Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für pädiatrische Endokrinologie und Diabetologie

Berlin, Germany

AOU Federico II

Naples, Campania, Italy

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Tuscany, Italy

Radboudumc Amalia Children's Hospital, Department of Pediatrics

Nijmegen, Gelderland, Netherlands

lnstytut Centrum Zdrowia Matki Polki, Klinika Endokrynologii i Chor6b Metabolicznych

Lodz, Poland, Poland

Uniwersytecki Szpital Kliniczny Nr 1 im. Prof. Tadeusza Sokotowskiego PUM w Szczecinie, Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie

Szczecin, West Pomeranian Voivodeship, Poland

Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street Hospital

London, United Kingdom

Manchester University NHS Foundation Trust, Royal Manchester Children's Hospital

Manchester, United Kingdom

Sheffield Children's Hospital NHS Trust, Sheffield Children's Hospital, Western Bank

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07159841

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