DelfaGLP-1 Atlas

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CompletedPhase 2Results posted

A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

121

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.1-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01104701
Org study IDBCB111

Timeline

Milestones

Study first posted2010-04-15estimated
Results first posted2014-07-17estimated
Last update posted2015-08-20estimated
Study start2010-05 (month precision)
Primary completion2010-12actual (month precision)
Study completion2010-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Is at least 18 years old at study start
•Has been diagnosed with type 2 diabetes mellitus
•Has HbA1c of 7.1% to 11.0%, inclusive, at study start
•Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start
•Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents

Exclusion criteria

•Clinically significant medical condition that could potentially affect study participation including:
•Acute or chronic pancreatitis
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
•Active cardiovascular disease within 3 months of study start
•Underlying hepatic or renal disease
•Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
•Has had > 2 episodes of major hypoglycemia in the preceding 6 months before study start
•Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
•Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
–Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
–Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start
–Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
–Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start
–Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
–Prescription or over-the-counter weight loss medications within 3 months prior to study start

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Glycemic / diabetes
3
Cardiometabolic biomarkers
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population

Time frame:Baseline (Day 1) to Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
2 mg Exenatide WeeklyChange from baseline to Week 2 (n=29,26,28,27)-0.31—
Change from baseline to Week 4 (n=29,26,28,27)-0.66—
Change from baseline to Week 6 (n=29,26,28,27)-1.26—
Change from baseline to Week 8 (n=28,26,28,27)-1.36—
Change from baseline to Weeks 9-11 (n=29,26,28,27)-1.73—
Change from baseline to Week 12 (n=28,26,28,27)-1.49—
Change from baseline to Week 13 (n=29,26,28,27)-1.96—
Change from baseline to Week 14 (n=29,26,28,27)-1.91—
Change from baseline to Week 15 (n=29,26,28,26)-1.84—
Change from baseline to Week 16 (n=29,26,28,27)-1.85—
Change from baseline to Weeks 17-19(n=29,26,28,27)-1.63—
Change from baseline to Week 20 (n=29,26,28,27)-1.36—
5 mg Exenatide MonthlyChange from baseline to Week 2 (n=29,26,28,27)0.32—
Change from baseline to Week 4 (n=29,26,28,27)-0.04—
Change from baseline to Week 6 (n=29,26,28,27)-0.74—
Change from baseline to Week 8 (n=28,26,28,27)-0.85—
Change from baseline to Weeks 9-11 (n=29,26,28,27)-0.57—
Change from baseline to Week 12 (n=28,26,28,27)-0.91—
Change from baseline to Week 13 (n=29,26,28,27)-1.20—
Change from baseline to Week 14 (n=29,26,28,27)-0.96—
Change from baseline to Week 15 (n=29,26,28,26)-1.34—
Change from baseline to Week 16 (n=29,26,28,27)-1.33—
Change from baseline to Weeks 17-19(n=29,26,28,27)-1.17—
Change from baseline to Week 20 (n=29,26,28,27)-1.10—
8 mg Exenatide MonthlyChange from baseline to Week 2 (n=29,26,28,27)0.31—
Change from baseline to Week 4 (n=29,26,28,27)0.32—
Change from baseline to Week 6 (n=29,26,28,27)-0.45—
Change from baseline to Week 8 (n=28,26,28,27)-0.33—
Change from baseline to Weeks 9-11 (n=29,26,28,27)-0.49—
Change from baseline to Week 12 (n=28,26,28,27)-0.33—
Change from baseline to Week 13 (n=29,26,28,27)-0.56—
Change from baseline to Week 14 (n=29,26,28,27)-0.76—
Change from baseline to Week 15 (n=29,26,28,26)-0.80—
Change from baseline to Week 16 (n=29,26,28,27)-0.26—
Change from baseline to Weeks 17-19(n=29,26,28,27)-0.58—
Change from baseline to Week 20 (n=29,26,28,27)-0.41—
11 mg Exenatide MonthlyChange from baseline to Week 2 (n=29,26,28,27)0.35—
Change from baseline to Week 4 (n=29,26,28,27)0.03—
Change from baseline to Week 6 (n=29,26,28,27)-0.74—
Change from baseline to Week 8 (n=28,26,28,27)-0.70—
Change from baseline to Weeks 9-11 (n=29,26,28,27)-0.83—
Change from baseline to Week 12 (n=28,26,28,27)-0.76—
Change from baseline to Week 13 (n=29,26,28,27)-0.97—
Change from baseline to Week 14 (n=29,26,28,27)-0.81—
Change from baseline to Week 15 (n=29,26,28,26)-1.24—
Change from baseline to Week 16 (n=29,26,28,27)-1.02—
Change from baseline to Weeks 17-19(n=29,26,28,27)-1.72—
Change from baseline to Week 20 (n=29,26,28,27)-1.14—

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population

Time frame:Baseline (Day 1) to 20 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percent of Hemoglobin95% CI
2 mg Exenatide WeeklyChange from baseline at Week 4 (n=29, 26, 28, 27)-0.52—
Change from baseline at Week 8 (n=25, 22, 25, 27)-1.15—
Change from baseline at Week 12 (n=29, 26, 28, 27)-1.43—
Change from baseline at Week 16 (n=29, 26, 28, 27)-1.58—
Change from baseline at Week 20 (n=29, 26, 28, 27)-1.54—
5 mg Exenatide MonthlyChange from baseline at Week 4 (n=29, 26, 28, 27)-0.33—
Change from baseline at Week 8 (n=25, 22, 25, 27)-0.89—
Change from baseline at Week 12 (n=29, 26, 28, 27)-1.30—
Change from baseline at Week 16 (n=29, 26, 28, 27)-1.40—
Change from baseline at Week 20 (n=29, 26, 28, 27)-1.29—
8 mg Exenatide MonthlyChange from baseline at Week 4 (n=29, 26, 28, 27)-0.24—
Change from baseline at Week 8 (n=25, 22, 25, 27)-1.03—
Change from baseline at Week 12 (n=29, 26, 28, 27)-1.19—
Change from baseline at Week 16 (n=29, 26, 28, 27)-1.41—
Change from baseline at Week 20 (n=29, 26, 28, 27)-1.31—
11 mg Exenatide MonthlyChange from baseline at Week 4 (n=29, 26, 28, 27)-0.34—
Change from baseline at Week 8 (n=25, 22, 25, 27)-0.91—
Change from baseline at Week 12 (n=29, 26, 28, 27)-1.26—
Change from baseline at Week 16 (n=29, 26, 28, 27)-1.43—
Change from baseline at Week 20 (n=29, 26, 28, 27)-1.45—
Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population

Time frame:Week 20

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of Participants95% CI
2 mg Exenatide Weekly< 7.0% HbA1c48.3—
≤ 6.5% HbA1c44.8—
5 mg Exenatide Monthly< 7.0% HbA1c50.0—
≤ 6.5% HbA1c26.9—
8 mg Exenatide Monthly< 7.0% HbA1c57.1—
≤ 6.5% HbA1c39.3—
11 mg Exenatide Monthly< 7.0% HbA1c70.4—
≤ 6.5% HbA1c48.1—
Secondary/protocol endpoint

Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population

Time frame:Baseline (Day 1) to Week 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
2 mg Exenatide WeeklyChange from baseline to Week 2 (n=29, 26, 28,27)-1.16—
Change from baseline to Week 4 (n=29, 25, 28,27)-21.7—
Change from baseline to Week 6 (n=28, 26, 28,27)-32.8—
Change from baseline to Week 8 (n=28, 26, 28,27)-40.8—
Change from baseline to Weeks 9-11 (n=29,26,27,27)-32.8—
Change from baseline to Weeks 12 (n=29,26,27,27)-44.8—
Change from baseline to Weeks 13 (n=29,26,28,27)-42.0—
Change from baseline to Weeks 14 (n=29,26,28,27)-36.3—
Change from baseline to Weeks 15 (n=29,26,28,26)-38.0—
Change from baseline to Weeks 16 (n=29,26,28,27)-34.5—
Change from baseline to Weeks17-19 (n=29,26,28,27)-33.3—
Change from baseline to Week 20 (n=29,26,28,27)-34.2—
5 mg Exenatide MonthlyChange from baseline to Week 2 (n=29, 26, 28,27)-12.9—
Change from baseline to Week 4 (n=29, 25, 28,27)-18.0—
Change from baseline to Week 6 (n=28, 26, 28,27)-42.6—
Change from baseline to Week 8 (n=28, 26, 28,27)-45.7—
Change from baseline to Weeks 9-11 (n=29,26,27,27)-40.2—
Change from baseline to Weeks 12 (n=29,26,27,27)-37.4—
Change from baseline to Weeks 13 (n=29,26,28,27)-38.0—
Change from baseline to Weeks 14 (n=29,26,28,27)-37.3—
Change from baseline to Weeks 15 (n=29,26,28,26)-37.3—
Change from baseline to Weeks 16 (n=29,26,28,27)-31.6—
Change from baseline to Weeks17-19 (n=29,26,28,27)-42.4—
Change from baseline to Week 20 (n=29,26,28,27)-25.1—
8 mg Exenatide MonthlyChange from baseline to Week 2 (n=29, 26, 28,27)-14.6—
Change from baseline to Week 4 (n=29, 25, 28,27)-14.2—
Change from baseline to Week 6 (n=28, 26, 28,27)-39.5—
Change from baseline to Week 8 (n=28, 26, 28,27)-36.8—
Change from baseline to Weeks 9-11 (n=29,26,27,27)-44.3—
Change from baseline to Weeks 12 (n=29,26,27,27)-45.4—
Change from baseline to Weeks 13 (n=29,26,28,27)-48.6—
Change from baseline to Weeks 14 (n=29,26,28,27)-47.5—
Change from baseline to Weeks 15 (n=29,26,28,26)-46.9—
Change from baseline to Weeks 16 (n=29,26,28,27)-43.3—
Change from baseline to Weeks17-19 (n=29,26,28,27)-34.6—
Change from baseline to Week 20 (n=29,26,28,27)-29.8—
11 mg Exenatide MonthlyChange from baseline to Week 2 (n=29, 26, 28,27)-23.5—
Change from baseline to Week 4 (n=29, 25, 28,27)-23.1—
Change from baseline to Week 6 (n=28, 26, 28,27)-48.8—
Change from baseline to Week 8 (n=28, 26, 28,27)-44.0—
Change from baseline to Weeks 9-11 (n=29,26,27,27)-48.1—
Change from baseline to Weeks 12 (n=29,26,27,27)-44.9—
Change from baseline to Weeks 13 (n=29,26,28,27)-45.7—
Change from baseline to Weeks 14 (n=29,26,28,27)-51.6—
Change from baseline to Weeks 15 (n=29,26,28,26)-53.1—
Change from baseline to Weeks 16 (n=29,26,28,27)-46.3—
Change from baseline to Weeks17-19 (n=29,26,28,27)-55.1—
Change from baseline to Week 20 (n=29,26,28,27)-48.9—

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population

Time frame:Baseline (Day 1), Week 20

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

GroupValue (mean), mmHg95% CI
2 mg Exenatide WeeklyDiastolic Blood Pressure-1.7—
Systolic Blood Pressure-2.3—
5 mg Exenatide MonthlyDiastolic Blood Pressure3.4—
Systolic Blood Pressure4.4—
8 mg Exenatide MonthlyDiastolic Blood Pressure1.8—
Systolic Blood Pressure0.5—
11 mg Exenatide MonthlyDiastolic Blood Pressure1.9—
Systolic Blood Pressure5.0—
Secondary/protocol endpoint

Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population

Time frame:Baseline (Day 1), Week 20

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), bpm95% CI
2 mg Exenatide Weekly2.8—
5 mg Exenatide Monthly3.9—
8 mg Exenatide Monthly5.6—
11 mg Exenatide Monthly-0.3—

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population

Time frame:Day 1 to Week 20

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (geometric_mean), pg/mL95% CI
2 mg Exenatide WeeklyCave(2016-2688h) pg/mL262.92—
Peak-Trough (2016-2688h) pg/mL171.27—
5 mg Exenatide MonthlyCave(2016-2688h) pg/mL127.13—
Peak-Trough (2016-2688h) pg/mL198.06—
8 mg Exenatide MonthlyCave(2016-2688h) pg/mL247.38—
Peak-Trough (2016-2688h) pg/mL424.47—
11 mg Exenatide MonthlyCave(2016-2688h) pg/mL218.07—
Peak-Trough (2016-2688h) pg/mL328.52—
Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population

Time frame:Day 1 to Study Termination (24 Weeks) or early Termination

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE

Posted result

GroupValue (number), participants95% CI
2 mg Exenatide WeeklyTreatment-Emergent AES27—
Treatment-Emergent SAEs0—
Treatment-Emergent AEs Leading to Discontinuation0—
5 mg Exenatide MonthlyTreatment-Emergent AES25—
Treatment-Emergent SAEs2—
Treatment-Emergent AEs Leading to Discontinuation0—
8 mg Exenatide MonthlyTreatment-Emergent AES20—
Treatment-Emergent SAEs0—
Treatment-Emergent AEs Leading to Discontinuation0—
11 mg Exenatide MonthlyTreatment-Emergent AES24—
Treatment-Emergent SAEs0—
Treatment-Emergent AEs Leading to Discontinuation1—
Secondary/protocol endpoint

Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population

Time frame:Day 1 through study termination (Week 24) or early termination.

event count, event

Posted result

GroupValue (number), participants95% CI
2 mg Exenatide Weekly6—
5 mg Exenatide Monthly8—
8 mg Exenatide Monthly3—
11 mg Exenatide Monthly6—
Secondary/protocol endpoint

Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population

Time frame:Day 1 to Study Termination (24 weeks) or early termination

Immunogenicity (ADA)

categorical status, event

Posted result

GroupValue (number), participants95% CI
2 mg Exenatide WeeklyWeek 2 Negative (n=30,30,30,30)27—
Week 2 Low Titer (<625)(n=30,30,30,30)3—
Week 2 High Titer (≥625)(n=30,30,30,30)0—
Week 20 Negative (n=30,26,29,28)7—
Week 20 Low Titer (<625)(n=30,26,29,28)15—
Week 20 High Titer (≥625)(n=30,26,29,28)8—
5 mg Exenatide MonthlyWeek 2 Negative (n=30,30,30,30)30—
Week 2 Low Titer (<625)(n=30,30,30,30)0—
Week 2 High Titer (≥625)(n=30,30,30,30)0—
Week 20 Negative (n=30,26,29,28)8—
Week 20 Low Titer (<625)(n=30,26,29,28)10—
Week 20 High Titer (≥625)(n=30,26,29,28)8—
8 mg Exenatide MonthlyWeek 2 Negative (n=30,30,30,30)30—
Week 2 Low Titer (<625)(n=30,30,30,30)0—
Week 2 High Titer (≥625)(n=30,30,30,30)0—
Week 20 Negative (n=30,26,29,28)9—
Week 20 Low Titer (<625)(n=30,26,29,28)15—
Week 20 High Titer (≥625)(n=30,26,29,28)5—
11 mg Exenatide MonthlyWeek 2 Negative (n=30,30,30,30)29—
Week 2 Low Titer (<625)(n=30,30,30,30)1—
Week 2 High Titer (≥625)(n=30,30,30,30)0—
Week 20 Negative (n=30,26,29,28)9—
Week 20 Low Titer (<625)(n=30,26,29,28)15—
Week 20 High Titer (≥625)(n=30,26,29,28)4—
Secondary/protocol endpoint

Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population

Time frame:Day 1 to study termination (24 weeks) or early termination

event count, event

componentshematocrit low, hemoglobin low, platelet low, platelet high

Posted result

GroupValue (number), laboratory values95% CI
2 mg Exenatide WeeklyWeek 6 Hematocrit (n=30,30,30,30)0—
Hematocrit at study termination (n=30,27,29,28)0—
Week 12 Platelets (n=30, 29, 30, 28)0—
5 mg Exenatide MonthlyWeek 6 Hematocrit (n=30,30,30,30)1—
Hematocrit at study termination (n=30,27,29,28)1—
Week 12 Platelets (n=30, 29, 30, 28)1—
8 mg Exenatide MonthlyWeek 6 Hematocrit (n=30,30,30,30)0—
Hematocrit at study termination (n=30,27,29,28)0—
Week 12 Platelets (n=30, 29, 30, 28)0—
11 mg Exenatide MonthlyWeek 6 Hematocrit (n=30,30,30,30)0—
Hematocrit at study termination (n=30,27,29,28)0—
Week 12 Platelets (n=30, 29, 30, 28)0—
Secondary/protocol endpoint/low confidence

Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population

Time frame:Day 1 to Study Termination (Week24) or early termination

event count, event

componentsTriglycerides, change, γ-GT, change

Posted result

GroupValue (number), laboratory values95% CI
2 mg Exenatide Weeklytriacylglycerol lipase Week 12 (n=30,29,29,28)1—
triacylglycerol lipase Week 20 (n=30,27,29,28)1—
Creatinine Week 6 (n=30,30,30,30)0—
Creatinine Week 12 (n=30,29,30,28)1—
Creatinine Week 20 (n=30,26,28,28)0—
Creatinine at study termination (n=30,26,29,28)0—
GGT Week 6 (n=30,30,30,30)2—
GGT Week 20 (n=30,26,28,28)1—
GGT study termination (n=30,26,29,28)1—
Bilirubin Week 6 (n=30,30,30,30)0—
Bilirubin Week 12 (n=30,29,30,28)0—
Urate Week 6 (n=30,30,30,30)1—
Urate Week 12 (n=30,29,30,28)0—
Urate Week 20 (n=30,26,28,28)0—
Urate Study termination (n=30,26,29,28)1—
Potassium Week 6 (n=30,30,30,30)1—
Calcium Week 6 (n=30,30,30,30)1—
5 mg Exenatide Monthlytriacylglycerol lipase Week 12 (n=30,29,29,28)1—
triacylglycerol lipase Week 20 (n=30,27,29,28)0—
Creatinine Week 6 (n=30,30,30,30)1—
Creatinine Week 12 (n=30,29,30,28)0—
Creatinine Week 20 (n=30,26,28,28)1—
Creatinine at study termination (n=30,26,29,28)0—
GGT Week 6 (n=30,30,30,30)0—
GGT Week 20 (n=30,26,28,28)0—
GGT study termination (n=30,26,29,28)0—
Bilirubin Week 6 (n=30,30,30,30)1—
Bilirubin Week 12 (n=30,29,30,28)1—
Urate Week 6 (n=30,30,30,30)1—
Urate Week 12 (n=30,29,30,28)3—
Urate Week 20 (n=30,26,28,28)1—
Urate Study termination (n=30,26,29,28)0—
Potassium Week 6 (n=30,30,30,30)0—
Calcium Week 6 (n=30,30,30,30)0—
8 mg Exenatide Monthlytriacylglycerol lipase Week 12 (n=30,29,29,28)0—
triacylglycerol lipase Week 20 (n=30,27,29,28)0—
Creatinine Week 6 (n=30,30,30,30)0—
Creatinine Week 12 (n=30,29,30,28)0—
Creatinine Week 20 (n=30,26,28,28)0—
Creatinine at study termination (n=30,26,29,28)1—
GGT Week 6 (n=30,30,30,30)0—
GGT Week 20 (n=30,26,28,28)1—
GGT study termination (n=30,26,29,28)1—
Bilirubin Week 6 (n=30,30,30,30)0—
Bilirubin Week 12 (n=30,29,30,28)0—
Urate Week 6 (n=30,30,30,30)2—
Urate Week 12 (n=30,29,30,28)1—
Urate Week 20 (n=30,26,28,28)2—
Urate Study termination (n=30,26,29,28)0—
Potassium Week 6 (n=30,30,30,30)0—
Calcium Week 6 (n=30,30,30,30)0—
11 mg Exenatide Monthlytriacylglycerol lipase Week 12 (n=30,29,29,28)0—
triacylglycerol lipase Week 20 (n=30,27,29,28)1—
Creatinine Week 6 (n=30,30,30,30)0—
Creatinine Week 12 (n=30,29,30,28)0—
Creatinine Week 20 (n=30,26,28,28)0—
Creatinine at study termination (n=30,26,29,28)0—
GGT Week 6 (n=30,30,30,30)0—
GGT Week 20 (n=30,26,28,28)0—
GGT study termination (n=30,26,29,28)0—
Bilirubin Week 6 (n=30,30,30,30)0—
Bilirubin Week 12 (n=30,29,30,28)0—
Urate Week 6 (n=30,30,30,30)2—
Urate Week 12 (n=30,29,30,28)2—
Urate Week 20 (n=30,26,28,28)2—
Urate Study termination (n=30,26,29,28)0—
Potassium Week 6 (n=30,30,30,30)0—
Calcium Week 6 (n=30,30,30,30)0—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.