Cagrilintide · research summary

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.

Clinical pharmacokinetics · 2026. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Two open-label, parallel-group pharmacokinetic studies assessing the effects of renal and hepatic impairment on cagrilintide.
“Two studies were conducted to assess the effects of renal or hepatic impairment on pharmacokinetics, safety and tolerability following single doses of cagrilintide.”

Subjects

Adult participants with normal function or mild, moderate, or severe renal or hepatic impairment.
“In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.”

Sample size

33 participants in the renal impairment study and 32 participants in the hepatic impairment study.
“The renal impairment study included 33 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 5) and the hepatic impairment study included 32 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 4).”

Duration

Pharmacokinetic assessment period from baseline to day 36 for the renal study and day 39 for the hepatic study.
“The primary endpoint was area under the cagrilintide plasma concentration curve from time zero extrapolated to infinity (AUC0–∞) from baseline (day 1) to day 36 (renal impairment study) or day 39 (hepatic impairment study).”

Reported findings

Total cagrilintide exposure and other pharmacokinetic parameters were similar across groups with no consistent patterns observed with renal or hepatic impairment.
“In both studies, total cagrilintide exposure (AUC0–∞), Cmax and other pharmacokinetic parameters were similar across groups with no consistent patterns observed with renal or hepatic impairment.”
No serious treatment-emergent adverse events, withdrawals, or deaths were reported in either study.
“In both studies, no serious TEAEs, TEAEs leading to study withdrawal or deaths were reported.”
No increase in the number of adverse events was observed with increasing renal or hepatic impairment.
“No increase in number of adverse events with increasing renal or hepatic impairment was observed, and no new safety or tolerability findings with cagrilintide were identified with renal or hepatic impairment.”

Source: PubMed 42228334 · DOI 10.1007/s40262-026-01654-0 · all study summaries

Subjects

Adult participants with normal function or mild, moderate, or severe renal or hepatic impairment.

“In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.”

Sample size

33 participants in the renal impairment study and 32 participants in the hepatic impairment study.

“The renal impairment study included 33 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 5) and the hepatic impairment study included 32 participants (normal function, n = 14; mild impairment, n = 7; moderate impairment, n = 7; severe impairment, n = 4).”

Duration

Pharmacokinetic assessment period from baseline to day 36 for the renal study and day 39 for the hepatic study.

“The primary endpoint was area under the cagrilintide plasma concentration curve from time zero extrapolated to infinity (AUC0–∞) from baseline (day 1) to day 36 (renal impairment study) or day 39 (hepatic impairment study).”

Reported findings

Total cagrilintide exposure and other pharmacokinetic parameters were similar across groups with no consistent patterns observed with renal or hepatic impairment.

“In both studies, total cagrilintide exposure (AUC0–∞), Cmax and other pharmacokinetic parameters were similar across groups with no consistent patterns observed with renal or hepatic impairment.”

No serious treatment-emergent adverse events, withdrawals, or deaths were reported in either study.

“In both studies, no serious TEAEs, TEAEs leading to study withdrawal or deaths were reported.”

No increase in the number of adverse events was observed with increasing renal or hepatic impairment.

“No increase in number of adverse events with increasing renal or hepatic impairment was observed, and no new safety or tolerability findings with cagrilintide were identified with renal or hepatic impairment.”