Eloralintide side effects

From trials and regulators9

Clinical studies and regulatory documents.

• Nausea

  Clinical study1

  11% (1 mg), 13% (3 mg), 64% (6 mg), 33% (9 mg), 54% (6 to 9 mg), 25% (3 to 9 mg) vs 14% on placebo over 48 weeks

  How people manage it

  • In the trial, the slow 3 to 6 to 9 mg climb had far less nausea than starting at 6 mg.

• Fatigue

  Clinical study1

  0% (1 mg), 13% (3 mg), 29% (6 mg), 43% (9 mg), 46% (6 to 9 mg), 21% (3 to 9 mg) vs 12% on placebo

• Vomiting

  Clinical study1

  7 of 28 people at 6 mg and 6 of 54 at 9 mg vs none of 53 on placebo; 1 of 52 in the slow 3 to 9 mg arm

• Constipation

  Clinical study1

  13 of 54 people at 9 mg vs 3 of 53 on placebo; 2 to 4 people in the other arms

• Hair loss

  Clinical study1

  6 of 54 people at 9 mg and 5 of 52 in the 3 to 9 mg arm vs none on placebo

• Slower heart rate

  Clinical study2

  Bradycardia in 3 people each in the 6 mg, 9 mg and 3 to 9 mg arms vs none on placebo; pulse fell during treatment in phase 1

• Mood changes

  Clinical study1

  4 of 100 phase 1 participants had mood-related events; the 3 on 12 mg stopped treatment and recovered in 2 to 4 days

  How people manage it

  • In phase 1, stopping the drug resolved the events within days.

• Injection-site reactions

  Clinical study1

  33.3% (3 mg), 21.7% (6 mg) and 13.9% (12 mg) of phase 1 cohorts vs 3.7% on placebo; mostly mild pain

• Stopping because of side effects

  Clinical study1

  0% to 10.8% on eloralintide alone vs 16.7% on placebo in the type 2 diabetes phase 2; 10.8% to 27.0% on EloraTZP