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TerminatedNCT01235741Updated Apr 15, 2015Results posted

A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

A Phase 2 interventional study of Pramlintide+Metreleptin and Placebo in Obesity, sponsored by AstraZeneca. Terminated at 18 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Why this study was terminated
Results from previous study DFA102 demonstrated neutralizing activity to metreleptin in invitro assay in 2 participants.
Phase
Phase 2
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.

02

Conditions studied

  • Obesity

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Keywords

  • Pramlintide
  • Metreleptin
  • Obesity
  • Amylin
  • Takeda
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 213 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Is obese with a BMI ≥35 to ≤45 kg/m2.
  • Has stable body weight (not varying by >5% within 3 months prior to study start).
  • Meets certain requirements with respect to concomitant medications.
  • Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

Exclusion criteria

Exclusion Criteria:

  • Has not been enrolled in a weight loss program within 2 months prior to study start.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
213 participants (actual)

Study arms

  • Experimental
    Group A

    Pramlintide+Metreleptin

    Drug: Pramlintide+Metreleptin

  • Placebo comparator
    Group B

    Placebo

    Drug: Placebo

Interventions

  • DrugPramlintide+Metreleptin

    Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.

  • DrugPlacebo

    Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population

    Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.

    Time frame: Day 1 up to Month 6 Follow-Up

  2. Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population

    Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).

    Time frame: Baseline to Month 6 Follow Up

  3. Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population

    Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.

    Time frame: Week 1 to Month 6 Follow-Up

  4. Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin

    In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.

    Time frame: Baseline to Month 6 Follow-Up

  5. Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population

    Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Platelets high (H) \>500,000/µL; low (L) \<75,000/µL. Hematocrit males \<36%, females \<30%. Hemoglobin males \<12 g/dL, females \<10 g/dL. White blood cell count (WBC) H \>18,000/µL; L \<1,500/µL. Urine protein H \>= 3+ or \>= 500 mg/dL. Urine glucose H \>= 3+ or \>= 500 mg/dL. Urine ketones \>= 3+ or Large.

    Time frame: Screening to 6 Month Follow-Up

  6. Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population

    Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Total bilirubin High (H) \> 2 mg/dL; Plasma or serum glucose fasting or non-fasting H \> 200 mg/dL, low (L) \< 60 mg/dL; Albumin L \<2.5 g/dL; Creatine kinase H \> 3\*Upper limit of Normal (ULN); Sodium L \<130 milliequivalents per liter (mEq/L), H \> 150 mEq/L; potassium L\<3.0 mEq/L, H\> 5.5 mEq/L; bicarbonate L\<18 mEq/L, H\>35 mEq/L;calcium L \<8mg/dL, H\> 11 mg/dL; triglycerides H\> 500 mg/dL; Cholesterol L \< 100 mg/dL, H \> 350 mg/dL; Alkaline phosphatase H \> 3\*ULN; Gamma-glutamyltransferase H\>3\*ULN; creatinine males \> 1.6 mg/dL, females \> 1.4 mg/dL; alanine aminotransferase H \> 3\*ULN; aspartate aminotransferase H \> 3\*ULN; urea nitrogen H \> 45 mg/dL; uric acid males \> 10.0 mg/dL, females \> 8.0 mg/dL; Phosphorus L \< 1.0 mg/dL H \> 6.0 mg/dL.

    Time frame: Screening to Month 6 Follow-Up

  7. Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).

    Time frame: Baseline to Month 6 Follow-Up

  8. Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).

    Time frame: Baseline up to Month 6 Follow-Up

  9. Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 Month Follow-Up

  10. Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).

    Time frame: Baseline up to Month 6 Follow-Up

  11. Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).

    Time frame: Baseline up to Month 6 Follow-Up

Secondary outcomes

  1. Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population

    Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.

    Time frame: Baseline up to Month 6 Follow-Up

07

Results

Posted Dec 9, 2013

Participant flow

5 January 2011 Lead-In Period started. 28 September 2011 last participants final visit procedure. Clinics where participants with body mass index \[BMI\] greater than, equal to (≥)35 kilogram per meter squared (kg/m\^2) and less than, equal to (≤)45 kg/m2) could be enrolled.

Non-Randomized Low Calorie Diet Lead-In
Participant flow — Non-Randomized Low Calorie Diet Lead-In
MilestoneLow Calorie Diet OnlyPlaceboPramlintide + Metreleptin
Started21300
Completed7200
Not completed14100
Withdrew: Withdrawal by subject900
Withdrew: Sponsor terminated study12100
Withdrew: Physician decision100
Withdrew: Protocol violation100
Withdrew: Lost to follow-up500
Withdrew: Failed to meet weight loss in period 1400
Randomized to Treatment
Participant flow — Randomized to Treatment
MilestoneLow Calorie Diet OnlyPlaceboPramlintide + Metreleptin
Started03636
Completed000
Not completed03636
Withdrew: Withdrawal by subject001
Withdrew: Adverse event011
Withdrew: Sponsor terminated study03534
Follow-Up Post Treatment up to Month 6
Participant flow — Follow-Up Post Treatment up to Month 6
MilestoneLow Calorie Diet OnlyPlaceboPramlintide + Metreleptin
Started03636
Completed02729
Not completed097
Withdrew: Withdrawal by subject036
Withdrew: Lost to follow-up051
Withdrew: Other010

Outcome measures

SecondaryPercent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.

Time frame:
Baseline up to Month 6 Follow-Up
Reported as:
Mean · percentage of change in weight
Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population
percentage of change in weightPlaceboPramlintide + Metreleptin
Week 1-0.34 ± 0.924-0.26 ± 0.819
6 Month Follow-Up-0.02 ± 6.575-1.80 ± 6.063
PrimaryNumber of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population

Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.

Time frame:
Day 1 up to Month 6 Follow-Up
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population
participantsOn Treatment PlaceboOn Treatment Pramlintide + MetreleptinPost Treatment Placebo ArmPost Treatment Pramlintide + Metreleptin Arm
Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population6131316
PrimaryChange From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population

Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).

Time frame:
Baseline to Month 6 Follow Up
Reported as:
Mean · ng/mL
Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population
ng/mLPramlintide + Metreleptin
Change from baseline to Week 2 of treatment223.38 ± 512.088
Change from baseline to Month 2 Follow up15.46 ± 34.885
Change from baseline to Month 4 Follow up20.08 ± 35.732
Month 6 Follow up10.70 ± 18.913
PrimaryNumber of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population

Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.

Time frame:
Week 1 to Month 6 Follow-Up
Reported as:
Number · participants
Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population
participantsPramlintide + Metreleptin
Week 10
Week 21
Early Termination9
Month 2 Follow-Up15
Month 4 Follow-Up10
Month 6 Follow-Up8
PrimaryNumber of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin

In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.

Time frame:
Baseline to Month 6 Follow-Up
Reported as:
Number · participants
Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin
participantsPramlintide + Metreleptin
Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin0
PrimaryNumber of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population

Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Platelets high (H) \>500,000/µL; low (L) \<75,000/µL. Hematocrit males \<36%, females \<30%. Hemoglobin males \<12 g/dL, females \<10 g/dL. White blood cell count (WBC) H \>18,000/µL; L \<1,500/µL. Urine protein H \>= 3+ or \>= 500 mg/dL. Urine glucose H \>= 3+ or \>= 500 mg/dL. Urine ketones \>= 3+ or Large.

Time frame:
Screening to 6 Month Follow-Up
Reported as:
Number · participants
Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population
participantsPlaceboPramlintide + Metreleptin
Hematocrit01
Hemoglobin01
Glucose in Urine01
PrimaryNumber of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population

Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Total bilirubin High (H) \> 2 mg/dL; Plasma or serum glucose fasting or non-fasting H \> 200 mg/dL, low (L) \< 60 mg/dL; Albumin L \<2.5 g/dL; Creatine kinase H \> 3\*Upper limit of Normal (ULN); Sodium L \<130 milliequivalents per liter (mEq/L), H \> 150 mEq/L; potassium L\<3.0 mEq/L, H\> 5.5 mEq/L; bicarbonate L\<18 mEq/L, H\>35 mEq/L;calcium L \<8mg/dL, H\> 11 mg/dL; triglycerides H\> 500 mg/dL; Cholesterol L \< 100 mg/dL, H \> 350 mg/dL; Alkaline phosphatase H \> 3\*ULN; Gamma-glutamyltransferase H\>3\*ULN; creatinine males \> 1.6 mg/dL, females \> 1.4 mg/dL; alanine aminotransferase H \> 3\*ULN; aspartate aminotransferase H \> 3\*ULN; urea nitrogen H \> 45 mg/dL; uric acid males \> 10.0 mg/dL, females \> 8.0 mg/dL; Phosphorus L \< 1.0 mg/dL H \> 6.0 mg/dL.

Time frame:
Screening to Month 6 Follow-Up
Reported as:
Number · participants
Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population
participantsPlaceboPramlintide + Metreleptin
Creatine Kinase23
Urate02
Bilirubin01
PrimaryMean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).

Time frame:
Baseline to Month 6 Follow-Up
Reported as:
Mean · mmHg
Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population
mmHgPlaceboPramlintide + Metreleptin
Systolic Blood Pressure4.3 ± 9.403.1 ± 8.90
Diastolic Blood Pressure2.7 ± 7.402.7 ± 8.07
PrimaryMean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).

Time frame:
Baseline up to Month 6 Follow-Up
Reported as:
Mean · beats/min
Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population
beats/minPlaceboPramlintide + Metreleptin
Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population1.2 ± 8.851.2 ± 7.98
PrimaryMean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).

Time frame:
Baseline to 6 Month Follow-Up
Reported as:
Mean · mg/dL
Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population
mg/dLPlaceboPramlintide + Metreleptin
Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population6.8 ± 8.31-1.0 ± 9.03
PrimaryMean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).

Time frame:
Baseline up to Month 6 Follow-Up
Reported as:
Mean · mU/L
Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population
mU/LPlaceboPramlintide + Metreleptin
Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population3.41 ± 8.9903.46 ± 7.617
PrimaryMean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).

Time frame:
Baseline up to Month 6 Follow-Up
Reported as:
Mean · mg/dL
Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population
mg/dLPlaceboPramlintide + Metreleptin
Total Cholesterol21.7 ± 19.2114.7 ± 25.51
HDL cholesterol7.7 ± 7.256.6 ± 7.60
LDL cholesterol14.0 ± 17.479.6 ± 21.05
Triglycerides10.4 ± 35.123.0 ± 38.30

Adverse events

Collected over Treatment emergent adverse events (AEs) and Serious AEs (SAEs): onset date/ time on or after first dose of randomized study medication and on or before the last dose of randomized study medication.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo-P + Placebo-M—0/36 (0%)1/36 (2.8%)
Pramlintide + Metreleptin—1/36 (2.8%)14/36 (38.9%)
Most frequent serious events
Most frequent serious events
EventPlacebo-P + Placebo-MPramlintide + Metreleptin
Coronary artery diseaseCardiac disorders0/361/36
Most frequent other events
Most frequent other events
EventPlacebo-P + Placebo-MPramlintide + Metreleptin
NauseaGastrointestinal disorders1/367/36
injection site hematomaGeneral disorders0/363/36
injection site indurationGeneral disorders0/362/36
injection site pruritusGeneral disorders0/362/36

Baseline characteristics

Baseline for all participants (213) was baseline at enrollment (Day 1 of Lead-in period); baseline for participants who were randomized to treatment before study was terminated was Day 1 of randomization (last measurement before first dose of assigned drug).

Age, Continuous
Age, Continuous(years)Non-Randomized Lead-in LCDPlaceboPramlintide + MetreleptinTotal
Mean46.1 ± 11.8146.2 ± 10.8446.4 ± 10.4546.1 ± 11.38
Sex: Female, Male
Sex: Female, Male(Participants)Non-Randomized Lead-in LCDPlaceboPramlintide + MetreleptinTotal
Female1062729162
Male359751
Region of Enrollment
Region of Enrollment(participants)Non-Randomized Lead-in LCDPlaceboPramlintide + MetreleptinTotal
United States1413636213
Body Weight
Body Weight(kg)Non-Randomized Lead-in LCDPlaceboPramlintide + MetreleptinTotal
Mean110.86 ± 13.210109.10 ± 16.850108.34 ± 12.032110.13 ± 13.678
Body Mass Index
Body Mass Index(kg/m^2)Non-Randomized Lead-in LCDPlaceboPramlintide + MetreleptinTotal
Mean39.51 ± 2.87539.17 ± 3.27939.09 ± 2.86939.38 ± 2.937
08

Study locations

18 sites
  • Research Site
    Greenbrae, California, United States
  • Research Site
    La Jolla, California, United States
  • Research Site
    Denver, Colorado, United States
  • Research Site
    Winter Park, Florida, United States
  • Research Site
    Chicago, Illinois, United States
  • Research Site
    Baton Rouge, Louisiana, United States
  • Research Site
    Hyattsville, Maryland, United States
  • Research Site
    Boston, Massachusetts, United States
  • Research Site
    St. Louis, Missouri, United States
  • Research Site
    Butte, Montana, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Tulsa, Oklahoma, United States
  • Research Site
    Philadelphia, Pennsylvania, United States
  • Research Site
    Austin, Texas, United States
  • Research Site
    Salt Lake City, Utah, United States
  • Research Site
    Arlington, Virginia, United States
  • Research Site
    Norfolk, Virginia, United States
  • Research Site
    Richmond, Virginia, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01235741
Lead sponsor
AstraZeneca
Collaborators
Takeda Pharmaceuticals North America, Inc.
Responsible party
Sponsor
First posted
Nov 7, 2010
Start date
Jan 2011
Primary completion
Sep 2011
Completion
Sep 2011
Results posted
Dec 9, 2013
Last update
Apr 15, 2015

Study contacts

Senior Vice President, Research & Development
study director · Amylin Pharmaceuticals, LLC.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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