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NCT04063488
The Effects of Metreleptin in Congenital Leptin Deficiency
trial testing Metreleptin in Congenital Leptin Deficiency (Disorder) in 2 participants. Completed in 13 August 2021.
13 August 2021
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2 |
| Start date | 20 June 2019 |
| Primary completion | 13 August 2021 |
| Estimated completion | 13 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metreleptin (METRELEPTIN) — full drug profile →
Conditions studied
- Congenital Leptin Deficiency (Disorder) — all drugs for Congenital Leptin Deficiency (Disorder) →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with Congenital Leptin Deficiency (Disorder). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study has been designed to 1) provide access to metreleptin to the only two individuals in the US known to have congenital leptin deficiency (CLD) and 2) explore a variety of unanswered questions about leptin physiology in general and metreleptin therapy in CLD specifically. The primary study endpoints include the following measures: body composition, measures of hepatic steatosis, measures of insulin sensitivity, and measures of sleep architecture. Secondary study endpoints include assessment of clock gene expression, body temperature, thyroid function, gonadal function, cognitive function, eating behavior, physical activity, mood, quality of life, and body image.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04063488
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metreleptin
Trials testing the same drug.
- NCT06502990 — Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy · Phase 3 · recruiting
- NCT06305182 — Metreleptin in Anorexia Nervosa · Phase 2 · recruiting
- NCT04026178 — Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy · Phase 4 · completed
- NCT02325674 — MEASuRE: Metreleptin Effectiveness And Safety Registry · recruiting
- NCT02654977 — CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystro · Phase 2 · completed
Other Northwestern University trials
Trials by the same sponsor.
- NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies · Phase 1, PHASE2 · not yet recruiting
- NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
- NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
- NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
- NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04063488 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 30 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04063488.
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