Atumelnant for Healthy Subjects

Overseen By Crinetics Clinical Trials

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Crinetics Pharmaceuticals Inc.

Must not be taking: Prescription medications

Disqualifiers: Pregnancy, Blood loss, Investigational drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how the body processes a new drug called atumelnant and to assess its safety and tolerability in healthy adults. Participants will receive either atumelnant or a placebo (a substance with no treatment effect) to determine any differences in the drug's behavior between Japanese and Caucasian individuals. The study seeks healthy individuals of Japanese or Caucasian descent, without significant diseases, and with normal morning cortisol levels (a hormone related to stress response). As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop taking my current medications to join the trial?

Yes, you need to stop taking any prescription medications unless you have approval from the study doctor. However, hormonal contraceptives and COVID-19 vaccines are allowed.

Is there any evidence suggesting that atumelnant is likely to be safe for humans?

Research has shown that atumelnant is usually well tolerated. In earlier studies, participants most commonly experienced mild to moderate headaches and nausea. While some may encounter these symptoms, they are not severe. This trial is in an early phase, focusing on understanding the drug's safety and how the body processes it. Although there is some evidence of safety, further research is necessary to confirm it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Atumelnant is unique because it offers a novel approach to treatment with its potential new mechanism of action, which could differentiate it from existing therapies. Unlike the standard of care, which might involve traditional medications or therapies that target symptoms in a conventional manner, Atumelnant may work by targeting specific pathways or receptors that are not addressed by current options. Researchers are excited about Atumelnant because it might offer increased efficacy or reduced side effects, improving the overall treatment experience and outcomes for patients.

What evidence suggests that atumelnant could be effective?

Research has shown that atumelnant offers promising results for people with congenital adrenal hyperplasia (CAH), a condition characterized by hormone imbalance. In one study, participants taking atumelnant experienced over a 90% reduction in A4 and a 97% reduction in 17-OHP, indicators of CAH, within just two weeks. Another study found improvements in serum cortisol, a hormone crucial for stress management and metabolism, with noticeable symptom relief. These findings suggest that atumelnant could help manage hormone imbalance conditions. However, more research is needed to fully understand its benefits and safety. Participants in this trial will receive either atumelnant or a placebo to further evaluate its effects in healthy subjects. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy Japanese and Caucasian adults. Specific criteria for joining or being excluded aren't provided, but typically participants must be in good health with no significant medical conditions.

Inclusion Criteria

Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, clinical chemistry, coagulation, serology, and urinalysis. The tests may be repeated once at Screening and at admission on Day -1 if necessary and deemed appropriate by the Investigator or designee

Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the Screening Visit and at admission on Day -1

Meeting the criteria at the time of consent for one of the following ethnic groups: Japanese participants must have been born in Japan to parents and grandparents of Japanese ethnic descent as evidenced by verbal confirmation and documented in a self-reported family tree form, have lived less than 10 years outside of Japan, and have no significant change in lifestyle, including diet, since leaving Japan. Caucasian participants must be considered White of European descent

Exclusion Criteria

Participant has received any investigational drug within the past 30 days or 5 half lives, whichever is longer, prior to the first dose of study intervention on Day 1

Participant is unwilling to refrain from strenuous, unaccustomed exercise and sports, defined as greater than 30 minutes per day, 3 days prior to admission on Day -1

Participant has history of hypersensitivity to study intervention or any of the excipients or to medicinal products with similar chemical structures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple QD oral doses of atumelnant or placebo

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atumelnant

Trial Overview The study is testing Atumelnant, a medication given once daily by mouth. It's compared to a placebo to see how the body processes it (pharmacokinetics) and whether it's safe and easy to tolerate over single and multiple doses.

How Is the Trial Designed?

Group I: Treatment (Cohort 2) Experimental Treatment 1 Intervention

Fixed-sequence cohort for Caucasian participants.

Group II: Treatment (Cohort 1) Experimental Treatment 1 Intervention

Fixed-sequence cohort for Japanese participants.

Group III: Placebo (Cohort 1) Active Control 1 Intervention

Fixed-sequence cohort for Japanese participants.

Group IV: Placebo (Cohort 2) Active Control 1 Intervention

Fixed-sequence cohort for Caucasian participants.

Who Is Running the Clinical Trial?

Crinetics Pharmaceuticals Inc.

Lead Sponsor

Trials

13

Recruited

760+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07144163

A Study to Evaluate Atumelnant in Adults With Congenital ... They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, ...

2. crinetics.com crinetics.com/crinetics-announces-positive-initial-findings-at-endo-2024-for-atumelnant-in-two-ongoing-open-label-studies-for-the-treatment-of-congenital-adrenal-hyperplasia-cah-and-acth-dependent-cushing/

News & Events Atumelnant (80 mg) CAH participants achieved more than a 90% reduction of A4 and 97% reduction of 17-OHP on atumelnant (80 mg), beginning at two weeks and ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-90915

Atumelnant for Healthy Subjects The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06712823

NCT06712823 | An Extension Study to Evaluate Safety and ... This single-arm, long-term, open-label, study is designed to evaluate the safety, tolerability, and efficacy of atumelnant (CRN04894) in participants with ...

5. synapse.patsnap.com synapse.patsnap.com/article/crinetics-reports-positive-early-results-at-endo-2024-for-atumelnant-in-cah-and-adcs-studies

Crinetics Reports Positive Early Results at ENDO 2024 for ... - Improvements in serum cortisol were observed in all participants, with at least two clinical symptoms improving in each case. Dr. Lynnette ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221084

NCT07221084 | A Study to Assess Pharmacokinetics ... The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11454873/

9330 Atumelnant (crn04894) Induces Rapid And Sustained ... We report preliminary data from the first-in-disease, dose-finding study of atumelnant in patients with ADCS (NCT05804669). ... Data are shown as median (range).