Trial · NCT00673387
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
NCT00673387, Phase 2, Completed, AstraZeneca; results first posted 2013-11-14
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ConductScience Library. Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects. Trials, record NCT00673387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00673387
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
- NCT number
- NCT00673387
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 636 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Overweight, Obesity
- Interventions
- pramlintide acetate, metreleptin, placebo-P, placebo-M
- First posted
- 2008-05-07
- Last updated
- 2015-04-15
- Results first posted
- 2013-11-14
- Limitations and caveats
Drug Randomization stratified:sex,3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total:8 treatment groups).
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups). |
| Secondary | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. |
| Secondary | Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population | Baseline to Week 28 | Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. |
| Secondary | LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population | Baseline to Week 28 | Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. |
| Secondary | LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population | Baseline to Weeks 12 and Week 28 | Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm). |
| Secondary | Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms\*hour/milliliter (pg\*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection. |
| Secondary | Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide | Weeks 4 and 24 | Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms\*hour/milliliter (pg\*h/mL). |
| Secondary | Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL). |
| Secondary | Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population | Baseline to Week 28 | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline. |
| Secondary | LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population | Baseline to Week 28 | Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k). |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | Percentage change in kg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | participants | NUMBER |
| SECONDARY | Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population | Baseline to Week 28 | Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented. | ng/mL | MEAN |
| SECONDARY | LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population | Baseline to Week 28 | Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population | Baseline to Weeks 12 and Week 28 | Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36. | pg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide | Weeks 4 and 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively. | pg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide | Week 4 and Week 24 | Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | percentage of body fat | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population | Baseline to Week 28 | Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28. | kg | LEAST_SQUARES_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group636
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Placebo | -2.01 | 95% Confidence Interval -3.76 to -0.26 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 360 mcg | -5.47 | 95% Confidence Interval -7.19 to -3.76 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Metreleptin 5.0 mg | -5.83 | 95% Confidence Interval -7.72 to -3.95 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 180 mcg + Metreleptin 2.5 mg | -6.85 | 95% Confidence Interval -8.61 to -5.08 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 180 mcg + Metreleptin 5.0 mg | -6.61 | 95% Confidence Interval -8.41 to -4.82 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 360 mcg + Metreleptin 1.25 mg | -6.39 | 95% Confidence Interval -8.18 to -4.59 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 360 mcg + Metreleptin 2.5 mg | -6.98 | 95% Confidence Interval -8.79 to -5.17 | Percentage change in kg | |
| Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population | Pramlintide 360 mcg + Metreleptin 5.0 mg | -7.02 | 95% Confidence Interval -8.94 to -5.10 | Percentage change in kg | |
| Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Placebo | Weight Loss >=5% | 10 | participants | |
| Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population | Pramlintide 360 mcg | Weight Loss >=5% | 27 | participants |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | STARTED | Pramlintide 360 mcg | 77 | |
| Overall Study | STARTED | Metreleptin 5.0 mg | 72 | |
| Overall Study | STARTED | Pramlintide 180 mcg + Metreleptin 2.5 mg | 75 | |
| Overall Study | STARTED | Pramlintide 180 mcg + Metreleptin 5.0 mg | 78 | |
| Overall Study | STARTED | Pramlintide 360 mcg + Metreleptin 1.25 mg | 78 | |
| Overall Study | STARTED | Pramlintide 360 mcg + Metreleptin 2.5 mg | 78 | |
| Overall Study | STARTED | Pramlintide 360 mcg + Metreleptin 5.0 mg | 75 | |
| Overall Study | COMPLETED | Placebo | 46 | |
| Overall Study | COMPLETED | Pramlintide 360 mcg | 54 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events304
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 | 4 | 75 | 4 |
| other | nausea | Gastrointestinal disorders | Pramlintide 360 mcg | 31 | 77 | 37 |
| other | nausea | Gastrointestinal disorders | Metreleptin 5.0 mg | 4 | 72 | 4 |
| other | nausea | Gastrointestinal disorders | Pramlintide 180 mcg + Metreleptin 2.5 mg | 27 | 75 | 30 |
| other | nausea | Gastrointestinal disorders | Pramlintide 180 mcg + Metreleptin 5.0 mg | 21 | 78 | 22 |
| other | nausea | Gastrointestinal disorders | Pramlintide 360 mcg + Metreleptin 1.25 mg | 26 | 78 | 27 |
| other | nausea | Gastrointestinal disorders | Pramlintide 360 mcg + Metreleptin 2.5 mg | 29 | 78 | 32 |
| other | nausea | Gastrointestinal disorders | Pramlintide 360 mcg + Metreleptin 5.0 mg | 19 | 75 | 20 |
| other | injection site erythema | General disorders | Placebo | 1 | 75 | 1 |
| other | injection site erythema | General disorders | Pramlintide 360 mcg | 7 | 77 | 8 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pramlintide 360 mcg | ||
| Total, all-cause mortality | Metreleptin 5.0 mg | ||
| Total, all-cause mortality | Pramlintide 180 mcg + Metreleptin 2.5 mg | ||
| Total, all-cause mortality | Pramlintide 180 mcg + Metreleptin 5.0 mg | ||
| Total, all-cause mortality | Pramlintide 360 mcg + Metreleptin 1.25 mg | ||
| Total, all-cause mortality | Pramlintide 360 mcg + Metreleptin 2.5 mg | ||
| Total, all-cause mortality | Pramlintide 360 mcg + Metreleptin 5.0 mg | ||
| Total, other adverse events | Placebo | 60 | 75 |
| Total, other adverse events | Pramlintide 360 mcg | 66 | 77 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26589105 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00673387/registered?page=2