Study of DISC-0974-201 in Participants With IBD and Anemia

NCT07368972 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DISC-0974-201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 13

Brief Summary

This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.

Conditions

Anemia; Inflammatory Bowel Disease (IBD); Inflammatory Bowel Disease (IBD); Anemia

Outcome Measures

Primary Outcomes (1)

• Maximal change from baseline in Hgb through Day 85

  up to 85 days

Secondary Outcomes (13)

• Incidence of treatment-emergent adverse events

  Up to 85 days

• Incidence of clinically abnormal vital signs

  Up to 85 days

• Incidence of clinically abnormal physical exam

  Up to 85 days

• Incidence of clinically abnormal electrocardiograms

  Up to 85 days

• Incidence of abnormal laboratory test results

  Up to 85 days

Study Arms (2)

Active

EXPERIMENTAL

DISC-0974 60 mg (n = 14) administered subcutaneously (SC) every 28 days for 3 doses

Drug: DISC-0974

Placebo

PLACEBO COMPARATOR

Placebo (n = 7) administered SC every 28 days for 3 doses

Drug: Placebo

Interventions

Placebo DRUG

Placebo is administered subcutaneously

Placebo

DISC-0974 DRUG

DISC-0974 is administered subcutaneously.

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:
• Aged ≥18 years at the time of signing informed consent.
• Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology.
• Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:
• a. CDAI of \<220 and SES-CD of 0 to 6 (CD/IBD-unclassified) modified Mayo Score of \<5 points and Mayo endoscopic subscore of 0 to 1 (UC/IBD-unclassified).
• Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.
• Hgb ≥7 AND \<12 g/dL for females and ≥7 AND \<13 g/dL for males (local lab) at screening.
• Have symptomatic anemia defined as:
• Hgb ≤10 g/dL and symptomatic as assessed by Investigator (fatigue, shortness of breath at rest or on minimal exertion, palpitations, tachycardia, orthostatic hypotension or dizziness), or
• Hgb \>10 g/dL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.
• Serum ferritin ≥75 μg/L at screening (local lab).
• AST and ALT \<2× upper limit of normal (ULN) at screening.
• Total and direct bilirubin \<ULN at screening.
• Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.
• If female, then EITHER postmenopausal (defined as at least 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \>40 mIU/mL, or at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) during the study and for at least 8 weeks after the last dose of study drug:

You may not qualify if:

• Participants meeting any of the following criteria at screening are not eligible for study enrollment:
• Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to screening labs for oral iron or iron-containing supplements. Between screening and 2 days prior to Day 1 visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron.
• Treatment within 30 days prior to screening with any of the following anemia treatments: blood transfusion, EPO-stimulating agent (ESA), or IV iron. Participants may be considered for the study if they undergo a 30-day washout period for ESAs or IV iron prior to screening labs.
• Planned change in IBD directed therapy within 3 months of screening.
• Moderate or severe IBD assessed during screening period. Defined as:
• CD/IBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7
• UC/IBD-unclassified: modified Mayo Score of ≥6 or endoscopic subscore of 3
• Fever, tachycardia, or anticipated need for surgery in the next 3 months
• Hospitalization within 30 days prior to screening.
• Positive direct antiglobulin test with reactive eluate at screening or medical history at screening of active hemolytic anemia.
• Gross gastrointestinal blood loss (eg, visible rectal bleeding, hematochezia, melena) within 4 weeks prior to screening.
• Active gastrointestinal bleeding requiring hospitalization, blood transfusion, or endoscopy hemostasis within 8 weeks prior to screening.
• Current use of Janus kinase (JAK) inhibitor.
• History of hereditary hemochromatosis.
• History of Primary Sclerosis Cholangitis.

Sponsors & Collaborators

• Disc Medicine, Inc: lead

Study Sites (13)

One of a Kind Clinical Research Center, LLC

Scottsdale, Arizona, 85258, United States

RECRUITING

Dolphin Medical Research

Doral, Florida, 33172, United States

RECRUITING

Clinical Research of Osceola, LLC

Kissimmee, Florida, 34741, United States

RECRUITING

Anchor Medical Research, LLC

Miami, Florida, 33176, United States

RECRUITING

Gastro Health - Galloway Care Center

Miami, Florida, 33176, United States

RECRUITING

Ezy Medical Research, Co

Miami Lakes, Florida, 33015, United States

RECRUITING

Guardian Angel Research, Inc

Tampa, Florida, 33614, United States

RECRUITING

KAD Clinical Research

St Louis, Missouri, 63123, United States

RECRUITING

Gastro Health - Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Gastro Health - Blue Ash Care Center

Cincinnati, Ohio, 45242, United States

RECRUITING

University Gastroenterology Clinical Research Department

Providence, Rhode Island, 02905, United States

RECRUITING

One of a Kind Clinical Research Center, LLC

Kingwood, Texas, 77339, United States

RECRUITING

Siena Research Network

Sugar Land, Texas, 77479, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anemia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Will Savage, MD, PhD

  Disc Medicine

  STUDY DIRECTOR

Central Study Contacts

Disc Medicine Clinical Trials

CONTACT

(617) 674 9274; clinicaltrials@discmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)