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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04815603




Registration number
NCT04815603
Ethics application status
Date submitted
8/03/2021
Date registered
25/03/2021

Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging
Scientific title
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
Secondary ID [1] 0 0
BGE-117-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGE-117
Other interventions - Placebo

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

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


Treatment: Drugs: BGE-117
Active Treatment

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin
Timepoint [1] 0 0
Day 85
Secondary outcome [1] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score
Timepoint [1] 0 0
Day 29, 57, 85 and Follow-up (up to 120 days)
Secondary outcome [2] 0 0
Hemoglobin
Timepoint [2] 0 0
Day 29, 57, and Follow-up (up to 120 days)
Secondary outcome [3] 0 0
Short Physical Performance Battery (SPPB) Score
Timepoint [3] 0 0
Day 29, 57, 85, and Follow-up (up to 120 days)
Secondary outcome [4] 0 0
6-minute Walk Test (6MWT) Distance
Timepoint [4] 0 0
Day 29, 57, 85, and Follow-up (up to 120 days)
Secondary outcome [5] 0 0
36-Item Short Form Survey Instrument (SF-36)
Timepoint [5] 0 0
Day 29, 57, 85, and Follow-up (Up to 120 days)
Secondary outcome [6] 0 0
BGE-117 Starting Dose Evaluation
Timepoint [6] 0 0
First dose to Day 85
Secondary outcome [7] 0 0
Grip Strength
Timepoint [7] 0 0
Day 29, 57, 85, and Follow-up (Up to 120 days)
Secondary outcome [8] 0 0
Clinical Global Impression (CGI) Measures
Timepoint [8] 0 0
Day 29, 57, 85, and Follow-up (Up to 120 days)

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
* 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)
* Systolic blood pressure = 160 mmHg or diastolic blood pressure = 95 mmHg (confirmed by repeated measurement) within 2 weeks before randomization. Note:

* Subjects being treated for hypertension should have been on a stable medication and dosing regimen for at least 8 weeks before randomization
* Subjects may be rescreened after their blood pressure is controlled
* Evidence of gastrointestinal bleeding within 12 weeks before Screening (Visit 1), as judged by the investigator
* Blood or plasma donation within 8 weeks before Screening (Visit 1) or at any time during the study period.
* Class III heart failure, as defined by the New York Heart Association (NYHA) functional classification system
* QTcF > 500 msec or QTcF > 530 msec in subjects with bundle branch block Note: This evaluation will be done only at Screening (Visit 1); ECG and corresponding intervals and overall interpretation can be mechanically or manually read by an appropriately designated and trained personnel.
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × the upper limit of normal (ULN)
* Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) Note: Bilirubin increases associated with Gilbert's syndrome are permitted.
* A reported average intake of alcohol of = 80 g/day (i.e., equivalent of 6 cans of beer or 5 shots of hard liquor)
* Increase in hemoglobin level to the target range (12.5-13.0 g/dL) would pose an unacceptable medical risk to the subject, as judged by the investigator
* History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product
* Use of another investigational agent within 30 days or 5 half-lives of the investigational agent; whichever is longer
* Prior randomization in the current study (BGE-117-201)
* Any current unstable medical condition that the investigator considers would put the subject at unacceptable risk, affect study compliance, or prevent the understanding of the study's objectives or investigational procedures or possible consequences. This includes:

* Current, unstable active liver or biliary disease (generally defined by the onset of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, or cirrhosis) Note: Stable liver disease (including asymptomatic gallstones, asymptomatic chronic hepatitis B, chronic hepatitis C, or Gilbert's syndrome) is acceptable if the subject otherwise meets entry criteria and the investigator and Sponsor approve entry into the study.
* Current or relevant history of a medical condition that may require inpatient treatment or make the subject unlikely to complete the study
* Unable or unwilling to adhere to the contraception requirements specified in the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research - Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Emeritus Research Sydney - Botany
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
Vale Medical Practice - Brookvale
Recruitment hospital [5] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [6] 0 0
Browns Plains Family (Sonic/IPN) - Browns Plains
Recruitment hospital [7] 0 0
Parkwood Family Practice (Sonic/IPN) - Gold Coast
Recruitment hospital [8] 0 0
AusTrials Taringa - Taringa
Recruitment hospital [9] 0 0
AusTrials Wellers Hill - Tarragindi
Recruitment hospital [10] 0 0
PARC Clinical Research - Adelaide
Recruitment hospital [11] 0 0
Casey Superclinic (Sonic/IPN) - Berwick
Recruitment hospital [12] 0 0
Emeritus Research - Camberwell - Camberwell
Recruitment hospital [13] 0 0
Camberwell Road Medical Practice (Sonic/IPN) - Hawthorn E.
Recruitment postcode(s) [1] 0 0
248 - Blacktown
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2100 - Brookvale
Recruitment postcode(s) [4] 0 0
2259 - Kanwal
Recruitment postcode(s) [5] 0 0
4118 - Browns Plains
Recruitment postcode(s) [6] 0 0
4214 - Gold Coast
Recruitment postcode(s) [7] 0 0
4068 - Taringa
Recruitment postcode(s) [8] 0 0
4121 - Tarragindi
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3806 - Berwick
Recruitment postcode(s) [11] 0 0
3124 - Camberwell
Recruitment postcode(s) [12] 0 0
3123 - Hawthorn E.

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioAge Labs, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04815603