Adverse effect · CagriSema

How common is GI side effects with CagriSema?

A
Grade A — established in humansBoth phase 3 RCTs · effect size: large · adverse
Short answerEstablished in humans. Both phase 3 RCTs point the same way: a large effect. Four in five people on the combination had gastrointestinal events in REDEFINE 1, against two in five on placebo; the same pattern in REDEFINE 2 (72.5% vs 34.4%). Mostly transient and mild to moderate, as with the parent drugs.

What the studies show

Four in five people on the combination had gastrointestinal events in REDEFINE 1, against two in five on placebo; the same pattern in REDEFINE 2 (72.5% vs 34.4%). Mostly transient and mild to moderate, as with the parent drugs.

“Gastrointestinal adverse events (affecting 79.6% in the cagrilintide-semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity.”

Verbatim, from the abstractGarvey WT, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1). N Engl J Med, 2025

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

  1. 1
  2. 2

In context

CagriSema is a once-weekly co-injection of cagrilintide, an amylin analogue, with semaglutide 2.4 mg. In REDEFINE 1, a 3,417-person phase 3 trial published in 2025, it produced 20.4% average weight loss at 68 weeks against 3.0% on placebo; in people with type 2 diabetes the figure was 13.7%. Both trials are peer-reviewed. It is not yet approved anywhere, and anything sold under the name is not the trial product.

CagriSema is investigational (filed). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is CagriSema proven to cause GI side effects?
Yes, as far as human trials can show it: Both phase 3 RCTs. LYO grades this outcome A.
What studies are behind the grade?
Four in five people on the combination had gastrointestinal events in REDEFINE 1, against two in five on placebo; the same pattern in REDEFINE 2 (72.5% vs 34.4%). Mostly transient and mild to moderate, as with the parent drugs.
Is CagriSema approved for this?
No. CagriSema is investigational (filed); it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for CagriSema

Written and maintained by LYO Research — how pages are written and checked. Reviewed 7 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →