Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging

NCT04815603 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: BGE-117-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 13

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.

Conditions

Anemia

Keywords

Anemia; BGE-117; BioAge

Outcome Measures

Primary Outcomes (1)

• Hemoglobin

  Change in Hemoglobin compared to baseline

  Day 85

Secondary Outcomes (8)

• Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score

  Day 29, 57, 85 and Follow-up (up to 120 days)

• Hemoglobin

  Day 29, 57, and Follow-up (up to 120 days)

• Short Physical Performance Battery (SPPB) Score

  Day 29, 57, 85, and Follow-up (up to 120 days)

• 6-minute Walk Test (6MWT) Distance

  Day 29, 57, 85, 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)

Other Outcomes (14)

• Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (AUC(0-24)/dose)

  Day 1, 29, 57, and 85

• Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Clearance)

  Day 1, 29, 57, and 85

• Analysis of Pharmacokinetic Parameters to Develop a Population Pharmacokinetic Model for BGE-117 (Volume of Distribution)

  Day 1, 29, 57, and 85

Study Arms (2)

BGE-117

EXPERIMENTAL

BGE-117 Capsules (4mg or 12mg) to be taken by mouth once a day for 84 days.

Drug: BGE-117

Placebo

PLACEBO COMPARATOR

Placebo Capsules to be taken by mouth once a day for 84 days.

Other: Placebo

Interventions

BGE-117 DRUG

Active Treatment

BGE-117

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Intravenous (IV) iron within 12 weeks before Screening (Visit 1) or during the Screening Period or Treatment Period. Rescue therapy with IV iron is permitted during the Follow-up Period if the subject's hemoglobin is below their baseline level. Note: oral iron supplementation is permitted. The subject must have started treatment with oral iron supplements at least 4 weeks before Screening. The same dose and dosing regimen should be maintained throughout the Screening Period and Treatment Period.
• Erythropoieisis-stimulating agent (ESA) treatment within 12 weeks before Screening (Visit 1) or during the Screening Period or Treatment Period. Rescue therapy with ESA is permitted during the Follow-up Period if the subject's hemoglobin level is below baseline.
• History of uncontrolled hypertension including:
• Difficult-to-control hypertension (unless approved by the investigator and the Medical Monitor)
• Malignant hypertension (unless approved by the investigator and the Medical Monitor)

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (13)

Paratus Clinical Research - Western Sydney

Blacktown, New South Wales, 248, Australia

Location

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

Location

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Vale Medical Practice

Brookvale, New South Wales, 2100, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Browns Plains Family (Sonic/IPN)

Browns Plains, Queensland, 4118, Australia

Location

Parkwood Family Practice (Sonic/IPN)

Gold Coast, Queensland, 4214, Australia

Location

AusTrials Taringa

Taringa, Queensland, 4068, Australia

Location

AusTrials Wellers Hill

Tarragindi, Queensland, 4121, Australia

Location

PARC Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Casey Superclinic (Sonic/IPN)

Berwick, Victoria, 3806, Australia

Location

Emeritus Research - Camberwell

Camberwell, Victoria, 3124, Australia

Location

Camberwell Road Medical Practice (Sonic/IPN)

Hawthorn E., Victoria, 3123, Australia

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

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: March 8, 2021
• First Posted: March 25, 2021
• Study Start: March 22, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (13)