AnemiaPhase 2NCT04815603
Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging
A Phase 2 study testing BGE-117 in people with Anemia, run by BioAge Labs, Inc. at 13 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- BGE-117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 13 sitesAustralia
- Study dates
- 22 Mar 2021to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 33Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
PARC Clinical Research
Adelaide, South Australia, 5000
Casey Superclinic (Sonic/IPN)
Berwick, Victoria, 3806
Paratus Clinical Research - Western Sydney
Blacktown, New South Wales, 248
Emeritus Research Sydney
Botany, New South Wales, 2019
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Vale Medical Practice
Brookvale, New South Wales, 2100
Browns Plains Family (Sonic/IPN)
Browns Plains, Queensland, 4118
Emeritus Research - Camberwell
Camberwell, Victoria, 3124
Parkwood Family Practice (Sonic/IPN)
Gold Coast, Queensland, 4214
Camberwell Road Medical Practice (Sonic/IPN)
Hawthorn E., Victoria, 3123
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
AusTrials Taringa
Taringa, Queensland, 4068
AusTrials Wellers Hill
Tarragindi, Queensland, 4121
About this study
Official 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
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- BGE-117, Placebo
- Keywords
- Anemia, BGE-117, BioAge
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGE-117Drug
Active Treatment
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BGE-117 | Experimental | BGE-117 Capsules (4mg or 12mg) to be taken by mouth once a day for 84 days. Receives: Drug: BGE-117 |
| Placebo | Placebo comparator | Placebo Capsules to be taken by mouth once a day for 84 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Change in Hemoglobin compared to baseline
Measured: Day 85
Secondary outcomes (8)
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score
Improvement in FACIT-Fatigue Score compared to baseline. The FACIT-Fatigue assessment is a 13-item questionnaire that assesses self-reported fatigue and its impact on daily activities and function. The scale is scored from 0 (Not at all) to 4 (Very Much). A lower score is considered improvement and a better outcome.
Measured: Day 29, 57, 85 and Follow-up (up to 120 days)
Hemoglobin
Change in Hemoglobin compared to baseline
Measured: Day 29, 57, and Follow-up (up to 120 days)
Short Physical Performance Battery (SPPB) Score
Change in SPPB Score compared to baseline. The SPPB assessment consists of a Balance Test, a Gait Speed Test, and a Chair Stand Test. Each of the three tests is scored from 0 to 4 points with a composite score from 0 to 12 points. A higher score is considered a better outcome.
Measured: Day 29, 57, 85, and Follow-up (up to 120 days)
6-minute Walk Test (6MWT) Distance
Change in 6MWT Distance compared to baseline. Increased distance is considered a better outcome.
Measured: Day 29, 57, 85, and Follow-up (up to 120 days)
36-Item Short Form Survey Instrument (SF-36)
Change in SF-36 compared to baseline. The SF-36 is a general health status questionnaire to assess patient perception of health in several domains, including physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health over the past 7 days. Each of the categories is scored from 0 to 100. A higher score is considered a better outcome.
Measured: Day 29, 57, 85, and Follow-up (Up to 120 days)
BGE-117 Starting Dose Evaluation
Evaluate the starting dose of BGE-117 in the treatment of anemia of aging for subjects with eGFR ≥ 60 mL/min/1.73 m2 and subjects with eGFR ≥ 30 and < 60 mL/min/ 1.73 m2
Measured: First dose to Day 85
Grip Strength
Evaluate the change in grip strength measures using the Jamar Hand Dynamometer grip strength test.
Measured: Day 29, 57, 85, and Follow-up (Up to 120 days)
Clinical Global Impression (CGI) Measures
Change in CGI measures compared to baseline. The CGI is a questionnaire-based instrument to assess subjects' progress and treatment response over time. The study will collect the CGI-Change of Condition to measure change in energy level and CGI-Therapeutic Efficacy to assess perceived therapeutic efficacy of treatment. A lower score is considered a better outcome.
Measured: Day 29, 57, 85, and Follow-up (Up to 120 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Mar 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815603
- Sponsor's protocol ID
- BGE-117-201
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04815603
- Acronym / sponsor ID
- BGE-117-201
- Conditions
- Anemia
- Keywords
- Anemia, BGE-117, BioAge
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGE-117 | Experimental | Drug: BGE-117BGE-117 Capsules (4mg or 12mg) to be taken by mouth once a day for 84 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Capsules to be taken by mouth once a day for 84 days. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (33 listed)
- History or diagnosis of any of the following:
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGE-117Active Treatment | Drug | BGE-117 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Hemoglobin
Time frame: Day 85
Change in Hemoglobin compared to baseline
8 secondary outcomes
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score
Time frame: Day 29, 57, 85 and Follow-up (up to 120 days)
Hemoglobin
Time frame: Day 29, 57, and Follow-up (up to 120 days)
Short Physical Performance Battery (SPPB) Score
Time frame: Day 29, 57, 85, and Follow-up (up to 120 days)
6-minute Walk Test (6MWT) Distance
Time frame: Day 29, 57, 85, and Follow-up (up to 120 days)
36-Item Short Form Survey Instrument (SF-36)
Time frame: Day 29, 57, 85, and Follow-up (Up to 120 days)
BGE-117 Starting Dose Evaluation
Time frame: First dose to Day 85
Grip Strength
Time frame: Day 29, 57, 85, and Follow-up (Up to 120 days)
Clinical Global Impression (CGI) Measures
Time frame: Day 29, 57, 85, and Follow-up (Up to 120 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGE-117 in people with Anemia, run by BioAge Labs, Inc. at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.