metreleptin for Partial Lipodystrophy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Partial Lipodystrophymetreleptin - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a daily injection of metreleptin is safe and effective for people with Partial Lipodystrophy.

Eligible Conditions
  • Partial Lipodystrophy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 12 months

12 months
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)
Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)
Safety analysis of AEs, AESIs, SAEs by treatment arm
6 months
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

metreleptin
1 of 2
placebo
1 of 2

Active Control

Non-Treatment Group

65 Total Participants · 2 Treatment Groups

Primary Treatment: metreleptin · Has Placebo Group · Phase 3

placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
metreleptin
Drug
ActiveComparator Group · 1 Intervention: metreleptin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Amryt PharmaLead Sponsor
4 Previous Clinical Trials
352 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

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