Trial · NCT01235741
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively. | percentage of change in weight | MEAN |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population | Day 1 up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. | participants | NUMBER |
| PRIMARY | Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population | Baseline to Month 6 Follow Up | All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively. | ng/mL | MEAN |
| PRIMARY | Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population | Week 1 to Month 6 Follow-Up | All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28. | participants | NUMBER |
| PRIMARY | Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin | Baseline to Month 6 Follow-Up | participants | NUMBER | |
| PRIMARY | Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population | Screening to 6 Month Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively. | participants | NUMBER |
| PRIMARY | Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population | Screening to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement. | participants | NUMBER |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population | Baseline to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement. | beats/min | MEAN |
| PRIMARY | Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population | Baseline to 6 Month Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up. | mg/dL | MEAN |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement. | mU/L | MEAN |
| PRIMARY | Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population | Baseline up to Month 6 Follow-Up | The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up. | mg/dL | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01235741/outcomes