PregnancyTLCNCT04090307
Targeted Lifestyle Change Group Prenatal Care
A study testing TLC Group Prenatal Care in people with Pregnancy and Gestational Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes
- What is being tested?
- TLC Group Prenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2019to 20 Oct 2025
- Phase
- Interventional
- 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- English speaking
- ≤16 weeks gestation
- Two or more of the following GDM risk factors:
- BMI ≥ 25
- Physical inactivity
- First degree relative with diabetes
Show all 19Show fewer
- High risk race or ethnicity (African American, Latino, Native American, Asian American, Pacific Islander)
- Prior infant weighing ≥ 4,000 g
- Prior GDM
- Hypertension (140/90 mm Hg or receiving treatment)
- High-density lipoprotein cholesterol level <35 mg/dL or triglycerides > 250 mg/dL
- Polycystic ovarian syndrome
- A1c ≥ 5.7%
- Impaired glucose tolerance
- Impaired fasting glucose on previous testing
- History of cardiovascular disease
- Ability to attend group prenatal visits at specified days and times
- Willingness to be randomized
- Ability to give informed consent
Who cannot join
- Type 2 diabetes (eligible for Diabetes Group Care)
- Positive glucose challenge test during early pregnancy
- Multiple gestation (require extra care)
- Major fetal anomaly (require extra care)
- Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
- Serious psychiatric illness, including schizophrenia, necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).
Read the detailed description
Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC. The objective is to conduct a randomized trial to determine the effect of TLC group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.
- Conditions
- Pregnancy, Gestational Diabetes
- Being tested
- TLC Group Prenatal Care
- Keywords
- Group Prenatal Care, Diabetes
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC Group Prenatal CareBehavioural
TLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.
| Study group | Role | What they receive |
|---|---|---|
| TLC Group Prenatal Care | Experimental | TLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health. Receives: Behavioral: TLC Group Prenatal Care |
| Traditional Prenatal Care | No intervention | Subjects randomized to routine care will receive their prenatal care with their primary obstetric provider. Patients are seen for 10-15 minutes every four weeks until 28 weeks' gestation, every two weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits focus on routine screening tests and prenatal care. Traditional care participants will receive a phone call once a month, until 28 weeks gestation, from a nurse practitioner to check-in on pregnancy goals, healthy eating, and exercise. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of TLC group prenatal care on birth weight
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Measured: Delivery/within 1 week of delivery
Effects of TLC group prenatal care on neonatal length
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Measured: Delivery/within 1 week of delivery
Effects on TLC group prenatal care on neonatal head circumference
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Measured: Delivery/within 1 week of delivery
Effects of TLC group prenatal care on infant skinfold thickness
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular
Measured: Delivery/within 1 week of delivery
Secondary outcomes (33)
Maternal diagnosis of gestational diabetes
Assessing maternal diagnosis of gestational diabetes using 2-step method(1-hour glucose challenge test, 3-hour glucose tolerance test, need for medication)
Measured: Up to the time of delivery
Physical activity and eating behavior
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on physical activity and eating behavior survey
Measured: At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
Maternal gestational weight gain
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal gestational weight gain
Measured: Initial visit through 4-12 weeks postpartum
Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal hypertensive disorders of pregnancy
Measured: Initial visit through 4-12 weeks postpartum
Rates of appointment attendance
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on number of prenatal visits attended
Measured: Up to the time of delivery
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on postpartum visit attendance
Measured: 4-12 weeks postpartum
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum contraception initiation
Measured: Delivery through 4-12 weeks postpartum
Breastfeeding rates among those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal breastfeeding
Measured: Delivery through 4-12 weeks postpartum
Postpartum weight retention
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal postpartum weight retention
Measured: Up to 12 weeks postpartum
Postpartum 2 hour glucose tolerance testing (if applicable)
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal glucose tolerance testing
Measured: 4-12 weeks Postpartum
Insulin resistance
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin resistance (fasting and 30 min insulin).
Measured: Through study completion, up to 12 weeks postpartum
Insulin sensitivity
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal insulin sensitivity (fasting and 30 min insulin).
Measured: Through study completion, up to 12 weeks postpartum
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal prenatal care satisfaction
Measured: Delivery
Neonatal gestational age at delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant gestational age at delivery
Measured: Delivery
Induction of labor rates for those in TLC compared to traditional prenatal care
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal induction of labor
Measured: Delivery
Mode of delivery for those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC)on maternal mode of delivery
Measured: Delivery
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant shoulder dystocia
Measured: Delivery
Neonatal APGAR score
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant APGAR score
Measured: Delivery
Neonatal cord blood analytes
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, c-peptide.
Measured: Delivery
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, pH.
Measured: Delivery
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant cord blood analytes, base excess.
Measured: Delivery
Neonatal NICU admission
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant NICU admission
Measured: Delivery
Neonatal hypoglycemia
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hypoglycemia
Measured: Delivery
Neonatal hematocrit
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant hematocrit
Measured: Delivery
Neonatal jaundice
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant jaundice
Measured: Delivery
Neonatal respiratory distress syndrome
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant respiratory distress syndrome
Measured: Delivery
Neonatal stillbirth
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant stillbirth
Measured: Delivery
Depression
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal depression using Edinburgh Postnatal Depression Scale
Measured: Enrollment through 4-12 weeks postpartum
Psychosocial stress
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal stress using the perceived stress scale
Measured: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal distress
Measured: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the life events checklist
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal life events
Measured: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal anxiety
Measured: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal sleep hygiene.
Measured: Enrollment through 4-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start26 Nov 2019
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Ebony B Carter, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090307
- Sponsor's protocol ID
- 23-2333
- Acronym
- TLC
- Status last verified
- Feb 2026
- First submitted
- 9 Aug 2019
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Lifestyle Change (TLC) Group Prenatal Care for Obese Women at High Risk for Gestational Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04090307
- Acronym / sponsor ID
- TLC / 23-2333
- Conditions
- Pregnancy, Gestational Diabetes
- Keywords
- Group Prenatal Care, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 16 Sep 2019 (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.
To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).
Detailed description
Long term, the investigator aims to test the central hypothesis that those in TLC will have better maternal and neonatal outcomes than those in TC. The objective is to conduct a randomized trial to determine the effect of TLC group prenatal care on birthweight and neonatal body composition, maternal healthy lifestyle and diabetes-related outcomes, delivery and neonatal outcomes, and psychosocial stress and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLC Group Prenatal Care | Experimental | Behavioral: TLC Group Prenatal CareTLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health. |
| Traditional Prenatal Care | No intervention | –Subjects randomized to routine care will receive their prenatal care with their primary obstetric provider. Patients are seen for 10-15 minutes every four weeks until 28 weeks' gestation, every two weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits focus on routine screening tests and prenatal care. Traditional care participants will receive a phone call once a month, until 28 weeks gestation, from a nurse practitioner to check-in on pregnancy goals, healthy eating, and exercise. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- English speaking
- ≤16 weeks gestation
- Two or more of the following GDM risk factors:
- BMI ≥ 25
- Physical inactivity
Key exclusion criteria (6 listed)
- Type 2 diabetes (eligible for Diabetes Group Care)
- Positive glucose challenge test during early pregnancy
- Multiple gestation (require extra care)
- Major fetal anomaly (require extra care)
- Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider (require extra care)
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 |
|---|---|---|
| TLC Group Prenatal CareTLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health. | Behavioural | TLC Group Prenatal Care |
Primary outcome
Effects of TLC group prenatal care on birth weight
Time frame: Delivery/within 1 week of delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant weight in grams
Effects of TLC group prenatal care on neonatal length
Time frame: Delivery/within 1 week of delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant length in cm
Effects on TLC group prenatal care on neonatal head circumference
Time frame: Delivery/within 1 week of delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant head circumference in cm
Effects of TLC group prenatal care on infant skinfold thickness
Time frame: Delivery/within 1 week of delivery
Determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on infant skinfold thickness of ilium, thigh, triceps, and subscapular
33 secondary outcomes
Maternal diagnosis of gestational diabetes
Time frame: Up to the time of delivery
Physical activity and eating behavior
Time frame: At enrollment, the last study visit/delivery, and 4-12 weeks postpartum
Maternal gestational weight gain
Time frame: Initial visit through 4-12 weeks postpartum
Maternal hypertensive disorders of pregnancy including gestational hypertension, chronic hypertension, preeclampsia, eclampsia, and HELLP
Time frame: Initial visit through 4-12 weeks postpartum
Rates of appointment attendance
Time frame: Up to the time of delivery
Rates of maternal postpartum visit attendance for those in TLC compared to traditional prenatal care
Time frame: 4-12 weeks postpartum
Rate of maternal contraception initiation for those in TLC compared to traditional prenatal care.
Time frame: Delivery through 4-12 weeks postpartum
Breastfeeding rates among those in TLC compared to traditional prenatal care.
Time frame: Delivery through 4-12 weeks postpartum
Postpartum weight retention
Time frame: Up to 12 weeks postpartum
Postpartum 2 hour glucose tolerance testing (if applicable)
Time frame: 4-12 weeks Postpartum
Insulin resistance
Time frame: Through study completion, up to 12 weeks postpartum
Insulin sensitivity
Time frame: Through study completion, up to 12 weeks postpartum
Assessing prenatal care patient satisfaction for those in TLC compared to traditional prenatal care using a satisfaction survey.
Time frame: Delivery
Neonatal gestational age at delivery
Time frame: Delivery
Induction of labor rates for those in TLC compared to traditional prenatal care
Time frame: Delivery
Mode of delivery for those in TLC compared to traditional prenatal care.
Time frame: Delivery
Neonatal shoulder dystocia rates for those in TLC compared to traditional prenatal care.
Time frame: Delivery
Neonatal APGAR score
Time frame: Delivery
Neonatal cord blood analytes
Time frame: Delivery
Neonatal cord blood analytes of pH for those in TLC compared to traditional prenatal care.
Time frame: Delivery
Neonatal cord blood analytes of base excess for those in TLC compared to traditional prenatal care.
Time frame: Delivery
Neonatal NICU admission
Time frame: Delivery
Neonatal hypoglycemia
Time frame: Delivery
Neonatal hematocrit
Time frame: Delivery
Neonatal jaundice
Time frame: Delivery
Neonatal respiratory distress syndrome
Time frame: Delivery
Neonatal stillbirth
Time frame: Delivery
Depression
Time frame: Enrollment through 4-12 weeks postpartum
Psychosocial stress
Time frame: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the pregnancy distress questionnaire
Time frame: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the life events checklist
Time frame: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the generalized anxiety disorder-7 test
Time frame: Enrollment through 4-12 weeks postpartum
Determine the effect of TLC on psychosocial stress and depression using the Munich Chronotype Questionnaire (MCTQ)
Time frame: Enrollment through 4-12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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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.
Ebony B Carter, MD, MPH principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLC Group Prenatal Care in people with Pregnancy and Gestational Diabetes, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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 19 inclusion and 6 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of TLC group prenatal care on birth weight (time frame: Delivery/within 1 week of delivery). The study lists 4 primary outcomes in all. 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 18 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.