GLP-1 Trial Landscape Intelligence Brief

Pipeline by Company

Company	Drug / Candidate	Indication	Phase	Status

Distribution by Phase

Trial Volume by Therapeutic Area

Analysis

The trial landscape is shifting. While obesity and T2D dominate volume, the growth rate in non-metabolic indications is accelerating — Alzheimer's, addiction, autoimmune, and renal programs have more than doubled since 2024. Novo Nordisk's Phase 3 Alzheimer's program and multiple addiction trials represent a strategic pivot: GLP-1 RAs are becoming multi-system therapeutic platforms. For protocol designers, this means rethinking endpoints entirely — cognitive scales, substance use biomarkers, and long-duration patient-reported outcomes require different measurement frameworks than HbA1c or body weight.

Market Size Forecast ($B USD) CAGR 17.6% · Source: ResearchAndMarkets

Pipeline Candidates by Sponsor

ALERT / Mar 2026: FDA issued a warning letter to Novo Nordisk for under-reporting serious adverse events for semaglutide, including unreported suicidal ideation. Reflects escalating post-market scrutiny as prescription volumes grow.

Active Safety Signals

Signal	Severity	Drugs	Trend

Label Changes (2025–2026)

Aug 2025 Wegovy label — MASH indication added (conditional)
Dec 2025 Oral Wegovy 25mg approved — first oral GLP-1 for weight loss
Dec 2025 Mounjaro pediatric expansion — T2D for ages 10+
Feb 2026 Oral Ozempic tablets — new strengths 1.5/4/9mg for T2D
Mar 2026 FDA warning letter — semaglutide AE reporting deficiencies

Regulatory Milestones & Catalysts

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data: clinicaltrials.gov · openfda · pubmed · company filings
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