Jill Kompa

A Phase 2 (2a) Randomized Trial of Iscalimab in Adolescents and Young Adults with New-Onset Type 1 Diabetes

Chantal Mathieu, Michelle Quinlan, Kristina Wagner, Jill Kompa et autres

Purpose: Iscalimab is a fully human, monoclonal anti-CD40 antibody that blocks CD154-induced CD40 signaling. Method: In a Phase 2 (2a) study, new-onset stage 3 type 1 diabetes mellitus (T1DM) participants were randomized 2:1 to iscalimab or placebo administered as a single intravenous …

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A Growth Differentiation Factor 15 Receptor Agonist in Randomized Placebo-Controlled Trials in Healthy or Obese Persons

William Burton Smith, D. Le Nguyen, Timothy M. Clough, J. Paul Schofield et autres

BACKGROUND: Growth differentiation factor 15 (GDF15), a divergent member of the TGF-β superfamily, signals via the hindbrain glial-derived neurotrophic factor receptor alpha-like and rearranged during transfection receptor co-receptor (GFRAL-RET) complex. In nonclinical species, GDF15 is a potent anorexigen leading to substantial weight …

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Gene expression signature predicts rate of type 1 diabetes progression

Tomi Suomi, Inna Starskaia, Ubaid Ullah, Omid Rasool et autres

BACKGROUND: Type 1 diabetes is a complex heterogenous autoimmune disease without therapeutic interventions available to prevent or reverse the disease. This study aimed to identify transcriptional changes associated with the disease progression in patients with recent-onset type 1 diabetes. METHODS: Whole-blood samples …

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LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia

Daniel James Rader, Eleftheria Maratos–Flier, A. Nguyen, Douglas Hom et autres

PURPOSE: To evaluate the safety and potential efficacy of LLF580, a genetically engineered variant of human fibroblast growth factor-21, for triglyceride lowering, weight loss, and hepatic fat reduction. METHODS: A multicenter, double-blind, parallel design trial in obese, mildly hypertriglyceridemic adults randomized (1:1) …

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Ways and Means to U.S. Registration of Foreign Drugs

Jill Kompa, David Skarinsky, Alberto Grignolo, Richard J. Schwen