Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants with CKD and Anemia

Inclusion criteria:

1. Aged ≥18 years of age at the time of signing informed consent.

2. Non-dialysis-dependent chronic kidney disease, Stages 2-5, defined as eGFR <90mL/min/1.73 m2 using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

3. Hgb <11.0 g/dL

4. Serum ferritin ≥50 μg/L at screening

5. Transferrin saturation ≤35%

6. AST and ALT <2× upper limit of normal (ULN) at screening

7. Total and direct bilirubin <ULN at screening

8. If female, then EITHER postmenopausal, defined as at least 12 months of natural,spontaneous amenorrhea and serum follicle-stimulating hormone >40 mIU/mL atscreening, or at least 6 weeks following surgical menopause (bilateral oophorectomyor hysterectomy); OR agreeable to use of highly effective contraception (listedbelow) on Day 1 (or earlier) for at least 8 weeks after the last dose of study drug:

• Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)

• Intrauterine device in place for at least 3 months

• Tubal ligation or single male partner with vasectomy in conjunction with abarrier method (eg, condom [male or female] or diaphragm)

9. If male with female sexual partner(s) of childbearing potential, agrees to use oneof the following acceptable methods of contraception during the study and for atleast 8 weeks after the last study drug dose:

10. Stable hormonal contraceptive (≥3 months; female partner) in conjunction with abarrier method (eg, condom or diaphragm [female partner])

11. Intrauterine device in place for at least 3 months (female partner)

12. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tuballigation (female partner) in conjunction with a barrier method (eg, condom [male or female] or diaphragm)

13. Confirmed successful vasectomy in conjunction with a barrier method (eg, condom [male or female] or diaphragm)

14. Able to understand and provide written informed consent

15. Able to comply with all study procedures

Exclusion Criteria:

1. Treatment within 2 days prior to screening with oral iron or iron-containingsupplements. Participants may be considered for the study if they undergo a 2-daywashout period prior to signing the informed consent form (ICF) and screening fororal iron or iron-containing supplements. Between screening and 2 days prior tobaseline visit, participants may continue oral iron or iron-containing supplementsat the discretion of the Investigator, but any study-related lab draws will requirea 48-hour washout from oral iron

2. Treatment within 30 days prior to screening with one of the following anemiatreatments: blood transfusion, ESAs, or IV iron. Participants may be considered forthe study if they undergo a 30-day washout period prior to signing the ICF andscreening for erythropoietin-stimulating agents or IV iron

3. Acute dialysis or acute kidney injury within 12 weeks prior to screening or expectedneed to start dialysis within 24 weeks of screening

4. Hospitalization for a CV, renal, or cardiorenal condition within 30 days prior toscreening

5. Positive direct antiglobulin test with reactive eluate at screening or activehemolytic anemia. This test can be performed prior to other screening proceduresafter the participant is consented for the prescreening testing

6. History of hereditary hemochromatosis

7. History of hemoglobinopathy or intrinsic red blood cell defect associated withanemia

8. History of total splenectomy

9. Hematopoietic stem cell or solid organ transplant within the past 10 years

10. Medical history of anemia from B12 or folate deficiency, infection, or bleeding inthe 3 months prior to screening

11. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterialembolism within 6 months prior to screening

12. If female, pregnant or breastfeeding

13. Any major surgery within 8 weeks before screening or incomplete recovery from anyprevious surgery

14. History of malignancy within the last 3 years. The following history/concurrentconditions are allowed: basal or squamous cell carcinoma skin cancer, carcinoma insitu of the cervix, carcinoma in situ of the breast, histologic finding of prostatecancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical stagingsystem). A history of completed treatment (medical or surgical) of Stage 1-2 cancersmay be permitted with prior Sponsor agreement

15. Participation in any other clinical protocol or investigational study that involvesadministration of experimental therapy and/or therapeutic devices within 30 days ofscreening

16. A history or known allergic reaction to any investigational product excipients orhistory of anaphylaxis to any food or drug

17. History of anti-drug antibody formation

18. History of inadequately controlled heart disease (New York Heart AssociationClassification 3 or 4) and/or have a known left ventricular ejection fraction <35%

19. Uncontrolled fungal, bacterial, or viral infection (defined as ongoingsigns/symptoms related to the infection without improvement, despite appropriatetreatment)

20. Human immunodeficiency virus positive, active hepatitis B, or active hepatitis C

21. Uncontrolled diabetes mellitus (defined as diabetes mellitus requiring initiation ofinsulin therapy within 3 months of screening)

22. Significant medical condition, laboratory abnormality, or psychiatric condition thatwould prevent the patient from participating in the study

23. Any condition or concomitant medication that would confound the ability to interpretdata from the study