A Phase 2a, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- BioAge Labs, Inc.
- Locations
- 13
- Primary Endpoint
- Hemoglobin
Overview
Brief Summary
The primary objectives of this study to evaluate the safety, tolerability and efficacy of BGE-117 in the treatment of anemia of aging in participants ≥ 65 years of age.
Detailed Description
This is a randomized, placebo-controlled, multicenter, double- blind study of BGE-117 administered PO in participants ≥ 65 years of age for the treatment of anemia of aging. Anemia of aging accounts for approximately one-third of anemia in patients over 65 years of age, defined as a suboptimal hemoglobin level due to different underlying characteristics. This study's planned size is 160 evaluable subjects (80 subjects randomized to BGE-117 and 80 subjects randomized to placebo).
After signing informed consent, participants may be Pre-screened for hemoglobin using HemoCue, and subsequently will be screened for study eligibility. Screening will include full physical examination, vital signs, safety and study-related laboratory evaluation, ophthalmic exam, ECG, Wells score for DVT, and clinical outcome assessment. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will be randomized to BGE-117 or placebo, PO, once per day, for a treatment period duration of approximately 12 weeks. Dose adjustments for study medication during the treatment period are made according to a dosing algorithm to achieve and maintain hemoglobin (Hb) within the target range (12.5-13.0 g/dL). Study procedures and assessments are performed at various timepoints during the treatment period per the schedule outlined in the study protocol. Participants will undergo follow-up assessments for approximately 4 weeks after administration of the last dose.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to voluntarily provide written, signed, and dated informed consent to participate in the study
- •An understanding, ability, and willingness to fully comply with study procedures and restrictions
- •Is 65 years of age or older at the time of Screening (Visit 1)
- •Anemia of Aging defined as a hemoglobin level in the range of ≥ 9.0 g/dL to ≤ 11.5 g/dL (≥ 90 g/L to ≤ 115 g/L) as determined by central laboratory measurement. (Note: For subjects with newly diagnosed anemia, appropriate investigations for the cause of the anemia should be completed according to standard-of-care under the direction of the subject's primary care physician.
- •Weight at Screening (Visit 1) is ≥ 40.0 kg
Exclusion Criteria
- •History or diagnosis of any of the following:
- •Anemia due to pernicious anemia, thalassemia, sickle cell anemia, sickle trait, or myelodysplastic syndromes
- •Bone-marrow hypoplasia or pure red cell aplasia
- •Androgen deprivation therapy within the previous12 months or radiation treatment for prostate cancer
- •Thyroid-stimulating hormone (TSH) \<0.1 mIU/L or \>10.0 mIU/L
- •Folic acid and Vitamin B12 levels less than the lower limit of normal range
- •eGFR as measured by Modification of Diet in Renal Disease (MDRD) \<30.0 mL/m/1.73 m2
- •Myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack, or pro thrombotic arrhythmia or condition (e.g., untreated atrial fibrillation) within 6 months before Screening or during the Screening (Visit 1).
- •Cancer diagnosis with active or uncertain disease (i.e. active malignancy), or are receiving active treatment within 12 weeks before Screening (Visit 1) (squamous cell or basal cell carcinoma of the skin are excluded from this criterion)
- •Suspected or history of hematologic malignancy. Remote or childhood hematologic malignancies may be permitted as judged by the investigator. Age-related clonal changes in hematopoiesis (e.g., clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of undetermined significance (CCUS)) are permitted as judged by the investigator.
Arms & Interventions
BGE-117
BGE-117 Capsules (4mg or 12mg) to be taken by mouth once a day for 84 days.
Intervention: BGE-117 (Drug)
Placebo
Placebo Capsules to be taken by mouth once a day for 84 days.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Hemoglobin
Time Frame: Day 85
Change in Hemoglobin compared to baseline
Secondary Outcomes
- 6-minute Walk Test (6MWT) Distance(Day 29, 57, 85, and Follow-up (up to 120 days))
- Hemoglobin(Day 29, 57, and Follow-up (up to 120 days))
- 36-Item Short Form Survey Instrument (SF-36)(Day 29, 57, 85, and Follow-up (Up to 120 days))
- Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score(Day 29, 57, 85 and Follow-up (up to 120 days))
- Grip Strength(Day 29, 57, 85, and Follow-up (Up to 120 days))
- Short Physical Performance Battery (SPPB) Score(Day 29, 57, 85, and Follow-up (up to 120 days))
- BGE-117 Starting Dose Evaluation(First dose to Day 85)
- Clinical Global Impression (CGI) Measures(Day 29, 57, 85, and Follow-up (Up to 120 days))