Gubra: CTA submitted for first-in-human study of lead asset GUB-UCN2
Summary
- Gubra has submitted a Clinical Trial Application for its obesity candidate GUB-UCN2 to German authorities, with clinical entry guided for H1 2026.
- The Phase 1/2a trial will involve approximately 188 participants, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy, particularly muscle volume and function.
- GUB-UCN2, based on the UCN2 mechanism, aims to reduce fat mass while preserving lean muscle, differentiating it from existing GLP-1 therapies.
- The CTA submission is a key milestone for Gubra, confirming execution and representing a de-risking event for its investment case.
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This morning Gubra announced the submission of a Clinical Trial Application (CTA) for the first-in-human study of GUB-UCN2, its internally owned obesity candidate, to the Competent Authority and Ethics Committee in Germany. Clinical entry remains guided for H1 2026.
The Phase 1/2a trial will enrol approximately 188 participants across healthy volunteers and individuals living with obesity, evaluating safety, tolerability, pharmacokinetics, and preliminary efficacy with a particular focus on muscle volume and muscle function endpoints. The trial will investigate GUB-UCN2 both as a standalone therapy and in combination with incretin-based treatment. A treatment period of up to 16 weeks is included in selected cohorts.
From an investment perspective, the CTA submission is the key near-term milestone for Gubra's internally owned pipeline. GUB-UCN2 is based on the UCN2 mechanism, which in preclinical studies has shown selective fat mass reduction while preserving or increasing lean muscle mass — a profile that differentiates it from approved GLP-1 therapies, where an estimated 20-45% of weight loss may come from lean tissue. The asset operates in a product class with limited direct competition, with peers still at early stages of development, and carries strong combination potential with existing GLP-1 therapies.
Such a submission has been within market expectations, but the announcement nonetheless confirms execution and represents a de-risking event for the investment case. The timing is also noteworthy from a competitive context: following the REDEFINE 4 readout earlier this week, in which CagriSema failed to demonstrate non-inferiority to tirzepatide despite delivering 23% weight loss, questions have been raised about the incremental value of adding an amylin analogue to an existing GLP-1 backbone in a crowded market. Against that backdrop, advancing a differentiated, internally owned candidate with a distinct mechanism — muscle preservation rather than pure weight loss magnitude — into the clinic is a timely step for Gubra
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Disclaimer: HC Andersen receives payment from Gubra for a Digital IR and research agreement/ Michael Friis 08:06 26/02/2026.