Trial · NCT01235741
A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
NCT01235741, Phase 2, Terminated, AstraZeneca; results first posted 2013-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects. Trials, record NCT01235741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01235741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
- NCT number
- NCT01235741
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 213 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Obesity
- Interventions
- Pramlintide+Metreleptin, Placebo
- First posted
- 2010-11-08
- Last updated
- 2015-04-15
- Results first posted
- 2013-12-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Day 1 up to Month 6 Follow-Up | 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. |
| Primary | Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Baseline to Month 6 Follow Up | 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). |
| Primary | Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population | Week 1 to Month 6 Follow-Up | 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. |
| Primary | Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin | Baseline to Month 6 Follow-Up | 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. |
| Primary | Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population | Screening to 6 Month Follow-Up | 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. |
| Primary | Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population | Screening to Month 6 Follow-Up | 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. |
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population | Baseline to Month 6 Follow-Up | 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). |
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population | Baseline up to Month 6 Follow-Up | 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). |
| Primary | Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population | Baseline to 6 Month Follow-Up | 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). |
| Primary | Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population | Baseline up to Month 6 Follow-Up | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively. | percentage of change in weight | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Day 1 up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. | participants | NUMBER |
| PRIMARY | Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Baseline to Month 6 Follow Up | All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively. | ng/mL | MEAN |
| PRIMARY | Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population | Week 1 to Month 6 Follow-Up | All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28. | participants | NUMBER |
| PRIMARY | Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin | Baseline to Month 6 Follow-Up | participants | NUMBER | |
| PRIMARY | Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population | Screening to 6 Month Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively. | participants | NUMBER |
| PRIMARY | Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population | Screening to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population | Baseline to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement. | beats/min | MEAN |
| PRIMARY | Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population | Baseline to 6 Month Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up. | mg/dL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population | Placebo | Week 1 | -0.34 | Standard Deviation 0.924 | 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 | Pramlintide + Metreleptin | Week 1 | -0.26 | Standard Deviation 0.819 | 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 | Placebo | 6 Month Follow-Up | -0.02 | Standard Deviation 6.575 | 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 | Pramlintide + Metreleptin | 6 Month Follow-Up | -1.80 | Standard Deviation 6.063 | percentage of change in weight |
| Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | On Treatment Placebo | 6 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | On Treatment Pramlintide + Metreleptin | 13 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Post Treatment Placebo Arm | 13 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Post Treatment Pramlintide + Metreleptin Arm | 16 | participants | ||
| Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Pramlintide + Metreleptin | Change from baseline to Week 2 of treatment | 223.38 | Standard Deviation 512.088 | ng/mL |
| Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Pramlintide + Metreleptin | Change from baseline to Month 2 Follow up | 15.46 | Standard Deviation 34.885 | ng/mL |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Non-Randomized Low Calorie Diet Lead-In | STARTED | Low Calorie Diet Only | 213 | |
| Non-Randomized Low Calorie Diet Lead-In | STARTED | Placebo | 0 | |
| Non-Randomized Low Calorie Diet Lead-In | STARTED | Pramlintide + Metreleptin | 0 | |
| Non-Randomized Low Calorie Diet Lead-In | COMPLETED | Low Calorie Diet Only | 72 | |
| Non-Randomized Low Calorie Diet Lead-In | COMPLETED | Placebo | 0 | |
| Non-Randomized Low Calorie Diet Lead-In | COMPLETED | Pramlintide + Metreleptin | 0 | |
| Non-Randomized Low Calorie Diet Lead-In | NOT COMPLETED | Low Calorie Diet Only | 141 | |
| Non-Randomized Low Calorie Diet Lead-In | NOT COMPLETED | Placebo | 0 | |
| Non-Randomized Low Calorie Diet Lead-In | NOT COMPLETED | Pramlintide + Metreleptin | 0 | |
| Randomized to Treatment | STARTED | Low Calorie Diet Only | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo-P + Placebo-M | 1 | 36 | 1 |
| other | Nausea | Gastrointestinal disorders | Pramlintide + Metreleptin | 7 | 36 | 9 |
| other | injection site hematoma | General disorders | Placebo-P + Placebo-M | 0 | 36 | 0 |
| other | injection site hematoma | General disorders | Pramlintide + Metreleptin | 3 | 36 | 3 |
| other | injection site induration | General disorders | Placebo-P + Placebo-M | 0 | 36 | 0 |
| other | injection site induration | General disorders | Pramlintide + Metreleptin | 2 | 36 | 2 |
| other | injection site pruritus | General disorders | Placebo-P + Placebo-M | 0 | 36 | 0 |
| other | injection site pruritus | General disorders | Pramlintide + Metreleptin | 2 | 36 | 2 |
| serious | Coronary artery disease | Cardiac disorders | Placebo-P + Placebo-M | 0 | 36 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Pramlintide + Metreleptin | 1 | 36 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-P + Placebo-M | ||
| Total, all-cause mortality | Pramlintide + Metreleptin | ||
| Total, other adverse events | Placebo-P + Placebo-M | 1 | 36 |
| Total, other adverse events | Pramlintide + Metreleptin | 14 | 36 |
| Total, serious adverse events | Placebo-P + Placebo-M | 0 | 36 |
| Total, serious adverse events | Pramlintide + Metreleptin | 1 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo-P + Placebo-M vs Pramlintide + Metreleptin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01235741/results?page=2