Trial · NCT00819234
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
NCT00819234, Phase 2, Completed, AstraZeneca; results first posted 2013-12-05
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ConductScience Library. Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin. Trials, record NCT00819234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00819234
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
- NCT number
- NCT00819234
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 274 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Obesity
- Interventions
- Placebo, Pramlintide and Metreleptin
- First posted
- 2009-01-08
- Last updated
- 2015-04-15
- Results first posted
- 2013-12-05
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Original Study Baseline to Week 52 | Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0. |
| Secondary | LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Original baseline to Week 52 | Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg). |
| Secondary | Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population | Original Study Baseline to Extension Week 52 and follow up | Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin. |
| Secondary | LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population | Baseline to Week 52 | Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock. |
| Secondary | LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population | Baseline to Week 52 | Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock). |
| Secondary | LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population | Baseline (Day 1) to Week 52 | Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock). |
| Secondary | LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population | Baseline to Week 52 | Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock). |
| Secondary | Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population | Baseline (Day 1) to Week 52 | Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (\>) 0% (Body weight gain); Change less than, equal to (\<=) 0 to \> -5% (No body weight change or body weight loss \<5%); Change \<= -5% (Body weight loss greater than, equal to (\>=)5%); Change \<= -5% to \> -10% (Body weight loss \>=5% and \<10%); Change \<= -10% (Body weight loss ≥10%); Change \<= -10% to \> -15% (Body weight loss \>=10% and \<15%); Change \<= -15% (Body weight loss \>=15%). |
| Secondary | Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population | Baseline (Week 28) to Week 52 | Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (\>) 0% (Body weight gain); Change less than, equal to (\<=) 0 to \> -5% (No body weight change or body weight loss \<5%); Change \<= -5% (Body weight loss greater than, equal to (\>=)5%); Change \<= -5% to \> -10% (Body weight loss \>=5% and \<10%); Change \<= -10% (Body weight loss ≥10%); Change \<= -10% to \> -15% (Body weight loss \>=10% and \<15%); Change \<= -15% (Body weight loss \>=15%). |
| Secondary | Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population | Screening to Week 52 | The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Original Study Baseline to Week 52 | Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock. | percentage of change in weight | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Original baseline to Week 52 | Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population | Original Study Baseline to Extension Week 52 and follow up | Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population | Baseline to Week 52 | n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population | Baseline to Week 52 | n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E. | Percentage of change in weight | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population | Baseline (Day 1) to Week 52 | n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population | Baseline to Week 52 | n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E. | µIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population | Baseline (Day 1) to Week 52 | Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population | Baseline (Week 28) to Week 52 | Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock. | participants | NUMBER |
| SECONDARY | Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population | Screening to Week 52 | Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock. | units on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group580
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Placebo - Stable | -2.68 | 95% Confidence Interval 2.170 | percentage of change in weight | |
| LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable | -9.92 | 95% Confidence Interval 2.203 | percentage of change in weight | |
| LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable | -9.24 | 95% Confidence Interval 1.944 | percentage of change in weight | |
| LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable | -8.20 | 95% Confidence Interval 2.201 | percentage of change in weight | |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Placebo - Stable | Week 12 (original study) | -4.59 | 95% Confidence Interval -6.55 to -2.62 | kg |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable | Week 12 (original study) | -6.72 | 95% Confidence Interval -8.71 to -4.73 | kg |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable | Week 12 (original study) | -7.31 | 95% Confidence Interval -9.07 to -5.55 | kg |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable | Week 12 (original study) | -7.06 | 95% Confidence Interval -9.05 to -5.07 | kg |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Placebo - Stable | Week 28 (Baseline for Extension) | -3.70 | 95% Confidence Interval -6.74 to -0.66 | kg |
| LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population | Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable | Week 28 (Baseline for Extension) | -8.63 | 95% Confidence Interval -11.72 to -5.55 | kg |
1 to 10 of 580Source ClinicalTrials.gov
See all 580 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo - Stable | 31 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 1.25mg Metreleptin - Stable | 35 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 2.5 Metreleptin - Stable | 36 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 5.0 Metreleptin - Stable | 28 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy | 13 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy | 14 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy | 13 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono | 29 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram | 37 | |
| Overall Study | STARTED | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram | 37 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events840
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 - Stable | 1 | 31 | 1 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 1.25mg Metreleptin - Stable | 3 | 35 | 3 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 2.5 Metreleptin - Stable | 2 | 36 | 2 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 5.0 Metreleptin - Stable | 5 | 28 | 5 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25 | 2 | 13 | 2 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5 | 1 | 14 | 1 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0 | 1 | 13 | 1 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono | 11 | 29 | 13 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram | 7 | 37 | 9 |
| other | nausea | Gastrointestinal disorders | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram | 8 | 37 | 12 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Stable | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 1.25mg Metreleptin - Stable | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 2.5 Metreleptin - Stable | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 5.0 Metreleptin - Stable | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25 | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5 | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0 | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram | ||
| Total, all-cause mortality | 360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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.
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