Phase 2
Completed N=273
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Source: ClinicalTrials.gov NCT00819234 ↗Enrolled (actual)
273
Serious AEs
1.5%
Results posted
Dec 2013
Primary outcomePrimary: 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 — -2.68; -9.92; -9.24; -8.20 percentage of change in weight — p=0.0135
Summary
Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-2.68; -9.92; -9.24; -8.20 | 0.0135 sig |
| 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 |
-4.59; -6.72; -7.31; -7.06; -3.70; -8.63 | — |
| SECONDARY Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population |
32.50; 34.48; 29.50; 102.02; 232.48; 420.24 | — |
| 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 |
-4.62; -4.03; -5.77; -5.70; -3.37; -6.48 | — |
| 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 |
-4.56; -6.93; -7.23; -7.17; -3.78; -9.14 | — |
| 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 |
-1.88; -0.60; 0.03; -6.29; 4.19; -2.21 | — |
| 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 |
-0.54; -2.16; -0.62; -1.61 | — |
| 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 |
3; 4; 10; 6; 6; 1 | — |
| 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 |
2; 1; 4; 1; 0; 0 | — |
| 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 |
-14.1; -14.4; -15.0; -21.4; -3.1; -22.6 | — |
| 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 |
-5.8; -5.7; -7.1; -7.4; -0.3; -10.4 | — |
| 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 |
-0.4; -1.2; -0.5; -0.2; -0.8; 0.1 | — |
| 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 |
-2.0; -2.5; -2.5; -1.3; 0.2; -3.9 | — |
| 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 |
32.50; 34.48; 29.50; 102.02; 232.48; 420.24 | — |
| SECONDARY Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population |
-1.0; 1.8; -4.6; -4.9; 0.7; 3.7 | — |
| SECONDARY Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population |
-3.1; -1.8; -3.1; -1.4; -1.6; 0.9 | — |
| SECONDARY Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population |
1.2; 1.2; 3.6; 0.6; 15.8; 6.0 | — |
| SECONDARY Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population |
0; 0; 4; 0; 0; 0 | — |
| SECONDARY Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population |
0; 0; 0; 1; 0; 0 | — |
| 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 |
20; 58; 71; 8; 7; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
- Male, or female and meets all the following criteria:
- Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
- If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
- Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria
- Is expected to require or undergo treatment with any exclusionary medication.
- Is undesirable as a study participant as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT00819234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.