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Active, not recruitingNCT03692052Updated Mar 30, 2026Results posted

A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

A Phase 2 interventional study of AG-348 in Thalassemia, sponsored by Agios Pharmaceuticals, Inc.. Active, not recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Agios Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Study AG348-C-010 is a multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of treatment with AG-348 in adult participants with non-transfusion-dependent thalassemia (NTDT). This study includes a core period (up to 24 weeks) followed by an extension period (up to 10 years) for eligible participants. 20 participants with NTDT were enrolled. The initial dose of AG-348 was 50 milligrams (mg) twice daily (BID) with one potential dose-level increase to 100 mg BID at the Week 6 visit based on the participant's safety and hemoglobin (Hb) concentrations.

02

Conditions studied

  • Thalassemia

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03

In context

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's enrollment of 20 is below the median of 37 across 277 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Agios Pharmaceuticals, Inc. is the lead sponsor of 52 studies on the registry; 6 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Informed consent;
  • Known medical history of thalassemia, including β-thalassemia intermedia, Hb E β-thalassemia, α-thalassemia (Hb H disease), or β-thalassemia with mutations of 1 or more α genes;
  • Documented clinical laboratory confirmation of thalassemia by Hb electrophoresis/high-performance liquid chromatography (HPLC) or deoxyribonucleic acid (DNA) analysis, either from medical records or during the screening period;
  • Hb concentration ≤10.0 grams per deciliter (g/dL), regardless of sex, based on an average of at least 2 Hb measurements (separated by a minimum of 7 days) during the screening period;
  • Considered non-transfusion-dependent, defined as having no more than 5 units of red blood cells (RBCs) transfused during the 24-week period up to the first day of study drug and no RBC transfusions in the 8 weeks prior to the first day of study drug;
  • Adequate organ function;
  • For women of reproductive potential: negative serum pregnancy test during the screening period and a negative serum or urine pregnancy test on Day 1;
  • For women of reproductive potential as well as men with partners who are women of reproductive potential: be abstinent as part of their usual lifestyle, or agreement to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of giving informed consent, during the study, and for 28 days following the last dose of study drug for women and 90 days following the last dose of study drug for men;
  • Willingness to comply with all study procedures for the duration of the study;

Exclusion criteria

Exclusion Criteria:

  • Known history of diagnosis of Hb S or Hb C forms of thalassemia;
  • Significant medical condition that confers an unacceptable risk to participating in the study, and/or could confound the interpretation of the study data;
  • Splenectomy scheduled during the study treatment period or having undergone splenectomy within 12 months prior to signing informed consent;
  • Currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo;
  • Exposure to any investigational drug, device, or procedure within 3 months prior to the first day of study drug;
  • Prior exposure to sotatercept (ACE-011), luspatercept (ACE-536), ruxolitinib, or gene therapy;
  • Prior bone marrow or stem cell transplant;
  • Currently pregnant or breastfeeding;
  • History of major surgery within 6 months of signing informed consent;
  • Currently receiving medications that are strong inhibitors of cytochrome P450 (CYP)3A4, strong inducers of CYP3A4, strong inhibitors of P-glycoprotein (P-gp), or digoxin (a P-gp sensitive substrate medication) that have not been stopped for a duration of at least 5 days or a timeframe equivalent to 5 half-lives (whichever is longer) prior to the first day of study drug;
  • Currently receiving chronic anticoagulant therapy, unless started and on a stable dose for at least 28 days prior to first day of study drug;
  • Currently receiving anabolic steroids, including testosterone preparations, if initiated ≤28 days prior to the first day of study drug;
  • Currently receiving hematopoietic stimulating agents (e.g., erythropoietins, granulocyte colony stimulating factors, thrombopoietins), if initiated ≤8 weeks prior to the first day of study drug;
  • History of allergy to sulfonamides if characterized by acute hemolytic anemia, drug-induced liver injury, anaphylaxis, rash of erythema multiforme type or Stevens-Johnson syndrome, cholestatic hepatitis, or other serious clinical manifestations;
  • History of allergy to AG-348 or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, and mannitol).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    AG-348

    Participants with alpha or beta thalassemia received AG-348 50 mg twice daily (BID), orally up to Week 6. Following Week 6, depending on the participants' safety and hemoglobin (Hb) concentrations, they could undergo one potential dose-level increase from 50 to 100 mg BID. After completion of the Core Period of 24 weeks, participants were eligible to continue to receive AG-348 in the Extension Period which is up to 10 years.

    Drug: AG-348

Interventions

  • DrugAG-348

    AG-348 tablet orally BID

    Also known as: Mitapivat

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving a Hemoglobin Response (HR)

    HR was defined as a ≥1.0 gram per deciliter (g/dL) increase in Hb concentration from Baseline at 1 or more assessments between Week 4 and Week 12 (inclusive). A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug.

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Average Change From Baseline in Hb Concentrations From Week 12 to Week 24

    A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug.

    Time frame: Baseline, Week 12 to Week 24

  2. Percentage of Participants Achieving a Sustained Hb Response (sHR)

    sHR was defined as achieving HR and achieving a ≥1.0 g/deciliter (dL) increase in Hb concentration at 2 or more evaluable Hb assessments out of the 4 scheduled assessments between the Week 12 visit and Week 24 visit.

    Time frame: Week 12 to Week 24

  3. Percentage of Participants Achieving a Delayed Hb Response

    Delayed Hb response was defined as not achieving HR and achieving a ≥1.0 g/dL increase in Hb concentration at 1 or more Hb assessments after Week 12.

    Time frame: Week 12 to Week 24

  4. Change From Baseline in Hb Concentration Over the Duration of the Extension Period

    Time frame: Baseline up to approximately 10.5 years

  5. Time to First ≥1.0 g/dL Increase in Hb Concentration

    Time frame: Up to Week 24

  6. Change From Baseline in Reticulocyte Count

    Time frame: Up to approximately 10.5 years

  7. Change From Baseline in Bilirubin

    Time frame: Up to approximately 10.5 years

  8. Change From Baseline in Lactate Dehydrogenase (LDH)

    Time frame: Up to approximately 10.5 years

  9. Change From Baseline in Haptoglobin

    Time frame: Up to approximately 10.5 years

  10. Change From Baseline in Nucleated Red Blood Cells (NRBCs)

    Time frame: Up to approximately 10.5 years

  11. Change From Baseline in Erythropoietin (EPO)

    Time frame: Up to approximately 10.5 years

  12. Change From Baseline in Soluble Transferrin Receptor

    Time frame: Up to approximately 10.5 years

  13. Drug Concentrations Over Time for AG-348

    Time frame: Predose (60 minutes) and 0.00 hour, 0.50 hour, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  14. AUC0-8h: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours of AG-348

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  15. AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of AG-348

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  16. Cmax: Maximum Observed Plasma Concentration of AG-348

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  17. Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  18. Tlast: Time of the Last Quantifiable Concentration of AG-348

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  19. Ctrough: Observed Plasma Concentration at the End of a Dosing Interval of AG-348

    Time frame: Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12

  20. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and TEAEs Leading to Study Drug Dose Reduction, Study Drug Interruption, and Study Drug Discontinuation

    An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important. AESIs are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol-specified transaminase increase.

    Time frame: From signing the inform consent form up to data cut-off date: 20 August 2020 (Up to approximately 19 months)

07

Results

Posted Nov 15, 2021

Participant flow

Participants took part in the study at 4 investigative sites in the United States, Canada, and United Kingdom from 28 December 2018 to 30 September 2030. Results are reported for the primary and secondary outcome measures for the 24-week Core Period (data cut-off date: 20 August 2020). The Extension Period of this study is ongoing.

Core Period (Day 1 to Week 24)
Participant flow — Core Period (Day 1 to Week 24)
MilestoneAG-348
Started20
Completed19
Not completed1
Withdrew: Adverse event1
Extension Period (Week 25 to 10 Years)
Participant flow — Extension Period (Week 25 to 10 Years)
MilestoneAG-348
Started19
Completed0
Not completed19
Withdrew: Withdrawal of consent1
Withdrew: Physician decision1
Withdrew: Ongoing17

Outcome measures

PrimaryPercentage of Participants Achieving a Hemoglobin Response (HR)

HR was defined as a ≥1.0 gram per deciliter (g/dL) increase in Hb concentration from Baseline at 1 or more assessments between Week 4 and Week 12 (inclusive). A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug.

Time frame:
Up to 12 weeks
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Hemoglobin Response (HR)
percentage of participantsAG-348
Percentage of Participants Achieving a Hemoglobin Response (HR)80.0 (59.90 to 92.86)
Statistical analysis
  • AG-348 · Clopper-Pearson Method · p = <.0001Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.
SecondaryAverage Change From Baseline in Hb Concentrations From Week 12 to Week 24

A participant's Baseline Hb concentration was defined as the average of all the participant's available Hb concentrations during the screening period up to the first dose of study drug.

Time frame:
Baseline, Week 12 to Week 24
Reported as:
Mean · grams per liter (g/L)
Average Change From Baseline in Hb Concentrations From Week 12 to Week 24
grams per liter (g/L)AG-348
Baseline79.44 ± 13.690
Average Change from Baseline: Week 12 to 2413.01 ± 6.283
SecondaryPercentage of Participants Achieving a Sustained Hb Response (sHR)

sHR was defined as achieving HR and achieving a ≥1.0 g/deciliter (dL) increase in Hb concentration at 2 or more evaluable Hb assessments out of the 4 scheduled assessments between the Week 12 visit and Week 24 visit.

Time frame:
Week 12 to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Sustained Hb Response (sHR)
percentage of participantsAG-348
Percentage of Participants Achieving a Sustained Hb Response (sHR)65.0 (44.20 to 82.27)
SecondaryPercentage of Participants Achieving a Delayed Hb Response

Delayed Hb response was defined as not achieving HR and achieving a ≥1.0 g/dL increase in Hb concentration at 1 or more Hb assessments after Week 12.

Time frame:
Week 12 to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Delayed Hb Response
percentage of participantsAG-348
Percentage of Participants Achieving a Delayed Hb Response10.0 (1.81 to 28.26)
SecondaryChange From Baseline in Hb Concentration Over the Duration of the Extension Period
Time frame:
Baseline up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryTime to First ≥1.0 g/dL Increase in Hb Concentration
Time frame:
Up to Week 24
Reported as:
Mean · weeks
Time to First ≥1.0 g/dL Increase in Hb Concentration
weeksAG-348
Time to First ≥1.0 g/dL Increase in Hb Concentration4.54 ± 3.204
SecondaryChange From Baseline in Reticulocyte Count
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Bilirubin
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Lactate Dehydrogenase (LDH)
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Haptoglobin
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Nucleated Red Blood Cells (NRBCs)
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Erythropoietin (EPO)
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryChange From Baseline in Soluble Transferrin Receptor
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryDrug Concentrations Over Time for AG-348
Time frame:
Predose (60 minutes) and 0.00 hour, 0.50 hour, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Drug Concentrations Over Time for AG-348
nanograms per milliliter (ng/mL)AG-348
AG-348 50 mg: 0.00 Hour, Day 1NA ± NA
AG-348 50 mg: 0.50 Hour, Day 1NA ± NA
AG-348 50 mg: 1 Hour, Day 1785.2 ± 64.6
AG-348 50 mg: 2 Hour, Day 1694.5 ± 26.6
AG-348 50 mg: 4 Hour, Day 1369.2 ± 29.4
AG-348 50 mg: 8 Hour, Day 1128.9 ± 55.1
AG-348 100 mg: 0.00 Hour, Week 1239.39 ± 117.1
AG-348 100 mg: 0.50 Hour, Week 121030 ± 137.7
AG-348 100 mg: 1 Hour, Week 121442 ± 30.6
AG-348 100 mg: 2 Hour, Week 12740.1 ± 76.3
AG-348 100 mg: 4 Hour, Week 12302.8 ± 75.2
AG-348 100 mg: 8 Hour, Week 1277.35 ± 48.2
SecondaryAUC0-8h: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours of AG-348
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Geometric mean · nanograms*hour per milliliter (ng*h/mL)
AUC0-8h: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours of AG-348
nanograms*hour per milliliter (ng*h/mL)AG-348
AG-348 50 mg: Day 13083.3 ± 25.6
AG-348 100 mg: Week 123384.4 ± 65.7
SecondaryAUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of AG-348
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Geometric mean · ng*h/mL
AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of AG-348
ng*h/mLAG-348
AG-348 50 mg: Day 13083.5 ± 25.6
AG-348 100 mg: Week 123384.4 ± 65.7
SecondaryCmax: Maximum Observed Plasma Concentration of AG-348
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Geometric mean · ng/mL
Cmax: Maximum Observed Plasma Concentration of AG-348
ng/mLAG-348
AG-348 50 mg: Day 1968.9 ± 38.1
AG-348 100 mg: Week 121476 ± 93.5
SecondaryTmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Median · hours
Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)
hoursAG-348
AG-348 50 mg: Day 11.07 (0.48 to 4.07)
AG-348 100 mg: Week 120.53 (0.43 to 2.03)
SecondaryTlast: Time of the Last Quantifiable Concentration of AG-348
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Median · hours
Tlast: Time of the Last Quantifiable Concentration of AG-348
hoursAG-348
AG-348 50 mg: Day 17.60 (7.50 to 8.02)
AG-348 100 mg: Week 127.55 (7.50 to 7.95)
SecondaryCtrough: Observed Plasma Concentration at the End of a Dosing Interval of AG-348
Time frame:
Predose (60 minutes) and 30 minutes, 1 hour, 2 hours, 4 hours, and 8 hours postdose on Day 1 and Week 12
Reported as:
Geometric mean · ng/mL
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval of AG-348
ng/mLAG-348
AG-348 100 mg: Week 1237.34 ± 117.7
SecondaryPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and TEAEs Leading to Study Drug Dose Reduction, Study Drug Interruption, and Study Drug Discontinuation

An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important. AESIs are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol-specified transaminase increase.

Time frame:
From signing the inform consent form up to data cut-off date: 20 August 2020 (Up to approximately 19 months)
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), and TEAEs Leading to Study Drug Dose Reduction, Study Drug Interruption, and Study Drug Discontinuation
percentage of participantsAG-348
TEAEs85.0
SAEs5.0
AESIs5.0
TEAEs Leading to Study Drug Dose Reduction15.0
TEAEs Leading to Study Drug Interruption5.0
TEAEs Leading to Study Drug Discontinuation5.0

Adverse events

Collected over Up to completion of the Core Period data cut-off date: 20 August 2020 (Up to approximately 19 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AG-3480/20 (0%)1/20 (5%)17/20 (85%)
Most frequent serious events
Most frequent serious events
EventAG-348
Renal impairmentRenal and urinary disorders1/20
Most frequent other events
Showing 10 of 80
Most frequent other events
EventAG-348
Initial insomniaPsychiatric disorders10/20
DizzinessNervous system disorders6/20
HeadacheNervous system disorders5/20
DyspepsiaGastrointestinal disorders4/20
FatigueGeneral disorders4/20
Upper respiratory tract infectionInfections and infestations4/20
CoughRespiratory, thoracic and mediastinal disorders4/20
Nasal congestionRespiratory, thoracic and mediastinal disorders4/20
Abdominal painGastrointestinal disorders3/20
DiarrhoeaGastrointestinal disorders3/20

Baseline characteristics

Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment.

Age, Continuous
Age, Continuous(years)AG-348
Mean45.3 ± 11.81
Sex: Female, Male
Sex: Female, Male(Participants)AG-348
Female15
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AG-348
Hispanic or Latino0
Not Hispanic or Latino19
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AG-348
American Indian or Alaska Native0
Asian10
Native Hawaiian or Other Pacific Islander1
Black or African American1
White4
More than one race0
Unknown or Not Reported4
08

Study locations

4 sites
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California 94609, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University Health Network (Toronto General Hospital)
    Toronto, Ontario M5G 2C4, Canada
  • Imperial College Healthcare NHS Trust (Hammersmith Hospital)
    London, W12 0HS, United Kingdom
09

References and documents

Publications

  • Kuo KHM, Layton DM, Lal A, Al-Samkari H, Bhatia J, Kosinski PA, Tong B, Lynch M, Uhlig K, Vichinsky EP. Safety and efficacy of mitapivat, an oral pyruvate kinase activator, in adults with non-transfusion dependent alpha-thalassaemia or beta-thalassaemia: an open-label, multicentre, phase 2 study. Lancet. 2022 Aug 13;400(10351):493-501. doi: 10.1016/S0140-6736(22)01337-X. PubMed 35964609 ↗

Study documents

  • Study protocol · Aug 26, 2020
  • Statistical analysis plan · Jul 27, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03692052
Lead sponsor
Agios Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 2, 2018
Start date
Mar 20, 2019
Primary completion
Aug 20, 2020
Completion
Sep 30, 2030 (estimated)
Results posted
Nov 15, 2021
Last update
Mar 30, 2026

Study contacts

Medical Affairs
study chair · Agios Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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