Trial · NCT00819234
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 |
| SECONDARY | Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - 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 |
| SECONDARY | Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total 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 |
| SECONDARY | Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - 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 |
| SECONDARY | Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population | Baseline to end of treatment follow up | number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68) | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population | Baseline (Day 1) to Week 52 | Enrolled and received at least 1 injection of any treatment; had data available. | mm Hg | MEAN |
| SECONDARY | Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population | Baseline to Week 52 | Enrolled and received at least 1 injection of any treatment; had data available. | bpm | MEAN |
| SECONDARY | Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population | Screening to Week 52 | Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52. | msec | MEAN |
| SECONDARY | Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population | Baseline to Week 52 | Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12); | number of laboratory values | NUMBER |
| SECONDARY | Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population | Baseline to Week 52 | All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37. | Number of Laboratory values | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population | Baseline to end of treatment follow up | N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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