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Terminus Peptides
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Research profile · Combination

Cagrilintide and semaglutide combination

Also known as CagriSema

Clinical — evidence level 4 of 4: Established clinical evidencePrescription only — UK regulatory status: Prescription-only medicine (UK)

Overview

An investigational combination with large phase 3 trials, containing a prescription-only medicine.

Category
Combination
Highest evidence level identified
Established clinical evidence
Last scientifically reviewed
20 August 2026
Last regulatory review
20 August 2026

Mechanism under investigation

This combines cagrilintide, a long-acting analogue of the pancreatic hormone amylin, with semaglutide, a GLP-1 receptor agonist. The two act on different appetite-regulating pathways — amylin signalling and incretin signalling — and the rationale is that engaging both suppresses appetite more than either alone. Unlike most combinations in this catalogue, that rationale has actually been tested against the single agents in randomised trials, and the combination did outperform semaglutide alone.

Research areas

  • Metabolic research
  • Combination pharmacology

These are fields in which the compound has been investigated. Listing a field is not a statement that anything was demonstrated within it.

Current evidence

In-vitro evidence

Cells, tissues or biochemical systems outside a living organism.

Characterised for each constituent as part of their development programmes.

Animal evidence

Studies in living non-human animals.

Established for each constituent through conventional preclinical development.

Human observational evidence

Studies observing people without assigning an intervention.

None. Use is confined to clinical trials.

Clinical-trial evidence

Studies assigning an intervention to human participants.

Extensive, and unusually for a combination, tested against its own constituents. A trial in Japan and Taiwan reported body-weight change at 68 weeks of −18.4 per cent with the combination against −11.9 per cent with semaglutide alone. In type 2 diabetes, a trial comparing the combination with each single agent found a greater fall in glycated haemoglobin than semaglutide alone (−1.91 against −1.75 percentage points). Further phase 3 trials studied it as initial therapy and as an addition to basal insulin. This is a genuine combination evidence base, not extrapolation from the parts.

Study limitations

  • Despite the trial programme, the combination is not approved anywhere in the world. An application was filed with the United States regulator in December 2025 with a decision expected late in 2026; no UK or European filing had been publicly confirmed at the time of review.
  • The trials are sponsored by the developer, and independent replication does not yet exist.
  • Semaglutide, one of the two constituents, is a prescription-only medicine in the UK. That governs the combination regardless of the combination’s own status.
  • Trial durations are long by the standards of this catalogue but still short relative to the chronic conditions studied, and cardiovascular outcome data for the combination are not available.

UK regulatory context

Prescription-only medicine (UK)

A medicine that may lawfully be supplied in the UK only against a prescription from an appropriate practitioner.

Source: The Human Medicines Regulations 2012, regulation 46 — prohibition on sale or supply of an unauthorised medicinal product (opens legislation.gov.uk in a new tab) (legislation.gov.uk)

Regulatory classification is jurisdiction-specific. A compound authorised elsewhere is not thereby authorised in the UK, and a supplier’s description of a substance does not determine how it is classified in law. See safety and regulation for the framework and the authoritative sources.

Safety and interpretation

The adverse-effect profile reported in trials is dominated by gastrointestinal events, consistent with both constituent classes. More importantly for anyone encountering this outside a trial: the combination has no marketing authorisation in any country, so no regulator anywhere has completed an assessment of its benefits and risks, and no approved product information exists. It also contains semaglutide, which in the UK may lawfully be supplied only against a prescription. Material sold under this name has been assessed by no one.

References