Trial · NCT00392925
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
NCT00392925, Phase 2, Completed, AstraZeneca; results first posted 2014-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects. Trials, record NCT00392925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00392925
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
- NCT number
- NCT00392925
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 177 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Overweight, Obesity
- Interventions
- pramlintide acetate 360 mcg, metreleptin, placebo-pramlintide 600 uL, placebo-metreleptin 1 mL, Pramlintide acetate 180 mcg
- First posted
- 2006-10-26
- Last updated
- 2015-04-14
- Results first posted
- 2014-02-28
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Baseline to Week 16 | Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment. |
| Secondary | LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Baseline up to Week 20 | Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment. |
| Secondary | LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population | Baseline to Week 20 | Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment |
| Secondary | LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20. |
| Secondary | LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20. |
| Secondary | Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population | Baseline to Week 20 | Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period). |
| Secondary | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population | Baseline to Weeks 16 and Weeks 20 | Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20. |
| Secondary | LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population | Enrollment to Baseline | Excess body weight: the difference between a participant's actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)\^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m\^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm. |
| Secondary | LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Enrollment to Week 20 | Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20. |
| Secondary | LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Baseline to Week 20 | Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm). |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Baseline to Week 16 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Baseline up to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population | Baseline to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population | Baseline to Week 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. | kg/week | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population | Baseline to Weeks 16 and Weeks 20 | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group. | participants | NUMBER |
| SECONDARY | LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population | Enrollment to Baseline | Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed. | percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Enrollment to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population | Baseline to Week 20 | Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group. | cm | LEAST_SQUARES_MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group361
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Metreleptin | -2.68 | Standard Error 0.952 | kg | |
| Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Pramlintide Acetate | -3.30 | Standard Error 0.698 | kg | |
| Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population | Pramlintide Acetate + Metreleptin | -6.46 | Standard Error 0.682 | kg | |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Metreleptin | Week 4 (n=19, 38, 36) | -0.70 | Standard Error 0.429 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Pramlintide Acetate | Week 4 (n=19, 38, 36) | -1.55 | Standard Error 0.310 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Pramlintide Acetate + Metreleptin | Week 4 (n=19, 38, 36) | -2.36 | Standard Error 0.311 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Metreleptin | Week 8 (n=19, 38, 36) | -2.08 | Standard Error 0.591 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Pramlintide Acetate | Week 8 (n=19, 38, 36) | -2.74 | Standard Error 0.427 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Pramlintide Acetate + Metreleptin | Week 8 (n=19, 38, 36) | -4.81 | Standard Error 0.429 | percentage of change |
| LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population | Metreleptin | Week 12 (n=19, 38, 36) | -3.17 | Standard Error 0.796 | percentage of change |
1 to 10 of 361Source ClinicalTrials.gov
See all 361 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 4 Week Lead-In Period - Non-Randomized | STARTED | Non-Randomized From 4 Week Lead-In | 177 | |
| 4 Week Lead-In Period - Non-Randomized | STARTED | Metreleptin | 0 | |
| 4 Week Lead-In Period - Non-Randomized | STARTED | Pramlintide Acetate | 0 | |
| 4 Week Lead-In Period - Non-Randomized | STARTED | Pramlintide Acetate + Metreleptin | 0 | |
| 4 Week Lead-In Period - Non-Randomized | COMPLETED | Non-Randomized From 4 Week Lead-In | 139 | |
| 4 Week Lead-In Period - Non-Randomized | COMPLETED | Metreleptin | 0 | |
| 4 Week Lead-In Period - Non-Randomized | COMPLETED | Pramlintide Acetate | 0 | |
| 4 Week Lead-In Period - Non-Randomized | COMPLETED | Pramlintide Acetate + Metreleptin | 0 | |
| 4 Week Lead-In Period - Non-Randomized | NOT COMPLETED | Non-Randomized From 4 Week Lead-In | 38 | |
| 4 Week Lead-In Period - Non-Randomized | NOT COMPLETED | Metreleptin | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events88
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 | Injection Site Bruising | General disorders | Placebo + Metreleptin | 3 | 27 | 3 |
| other | Injection Site Bruising | General disorders | Pramlintide + Placebo | 9 | 56 | 11 |
| other | Injection Site Bruising | General disorders | Pramlintide + Metreleptin | 11 | 56 | 13 |
| other | Injection Site Bruising | General disorders | Participants Not Randomized to Group After Lead-In Period | 1 | 38 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo + Metreleptin | 7 | 27 | 7 |
| other | Nausea | Gastrointestinal disorders | Pramlintide + Placebo | 8 | 56 | 10 |
| other | Nausea | Gastrointestinal disorders | Pramlintide + Metreleptin | 7 | 56 | 8 |
| other | Nausea | Gastrointestinal disorders | Participants Not Randomized to Group After Lead-In Period | 10 | 38 | 10 |
| other | Injection Site Erythema | General disorders | Placebo + Metreleptin | 5 | 27 | 5 |
| other | Injection Site Erythema | General disorders | Pramlintide + Placebo | 6 | 56 | 8 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Metreleptin | ||
| Total, all-cause mortality | Pramlintide + Placebo | ||
| Total, all-cause mortality | Pramlintide + Metreleptin | ||
| Total, all-cause mortality | Participants Not Randomized to Group After Lead-In Period | ||
| Total, other adverse events | Placebo + Metreleptin | 24 | 27 |
| Total, other adverse events | Pramlintide + Placebo | 42 | 56 |
| Total, other adverse events | Pramlintide + Metreleptin | 45 | 56 |
| Total, other adverse events | Participants Not Randomized to Group After Lead-In Period | 17 | 38 |
| Total, serious adverse events | Placebo + Metreleptin | 1 | 27 |
| Total, serious adverse events | Pramlintide + Placebo | 0 | 56 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
GET https://conductscience.org/api/trials/v1/NCT00392925
GET https://conductscience.org/api/trials/v1/NCT00392925/registered?page=2