Peptide Graded

Lixisenatide

Does Lixisenatide work?

Yes, in large controlled trials: a trial of 6,068 people.

AStrong human evidenceFDA approvedas of 2026-10-26

The glucose-lowering indication rests on the GetGoal phase 3 program summarized in the label, and ELIXA, a randomized placebo-controlled cardiovascular outcomes trial in 6,068 patients after an acute coronary syndrome, established cardiovascular safety. The gap is that lixisenatide showed no cardiovascular benefit and only modest weight loss, so its evidence supports safety and glycemic control, not the outcomes that newer GLP-1 drugs achieved. 12

ELIXA randomized 6,068 adults with type 2 diabetes to lixisenatide or placebo. All had had a heart attack or unstable angina in the previous 180 days. They were followed for a median of 25 months. The main composite was cardiovascular death, heart attack, stroke, or hospitalization for unstable angina. It happened in 13.4 percent on lixisenatide and 13.2 percent on placebo. Lixisenatide met the non-inferiority criterion. It did not show superiority. Weight fell a little more than with placebo. 2

Trials of sugar control behind the label show drops in HbA1c. The drops were biggest in post-meal glucose. The comparison was with placebo. This held on its own. It also held when the drug was added to metformin, sulfonylureas, or basal insulin. 1

Evidence checklist

  • Randomised controlled trial ELIXA and GetGoal placebo-controlled trials
  • Human study over 100 people ELIXA 6,068 patients
  • More than one research group Sponsor-run program; no independent group cited
  • Clinical outcomes, not surrogate markers ELIXA: no cardiovascular benefit or harm
  • Human safety data beyond case reports Trial and label safety data

Read the full Lixisenatide page

More on Lixisenatide

Citations

  1. FDA 2024: Adlyxin (lixisenatide) prescribing information accessdata.fda.gov
  2. Pfeffer 2015, NEJM: Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA) doi.org
  3. RxLess 2022: Adlyxin will no longer be available in the US rxless.com

Reference information only, not medical advice. Drawn from the Lixisenatide article, fact-checked against the cited sources. No dosing anywhere on this site.