Soliqua: The Insulin-and-GLP-1 Pen, What Its Trials Showed, and How It Differs From Ozempic

Soliqua is two diabetes drugs in one pen: the long-acting insulin glargine and the GLP-1 drug lixisenatide. It is a once-daily injection for adults with type 2 diabetes, approved in the United States in November 2016, and it is the only way lixisenatide currently appears among the labels on DailyMed. It is not a weight-loss drug, and it is not Ozempic.

This page sets out what the label and the two pivotal trials report. Records were read on 14 October 2026; the label is Sanofi's version effective 18 March 2026.

What is in the pen

Source: Soliqua 100/33 label, sections 2.1, 3 and 11.

The fixed ratio is the defining feature: the two drugs move together. The label sets the maximum at 60 units a day, which is 20 mcg of lixisenatide. Under its limitations of use it is not recommended with any other GLP-1 drug, has not been studied with mealtime insulin, and is not for diabetic ketoacidosis. Its approved use is blood-sugar control in adults with type 2 diabetes.

What lixisenatide is. It is a GLP-1 receptor agonist that was also approved alone, as Adlyxin, on 27 July 2016 (BLA 208471). Drugs@FDA still shows that application as "Prescription", but a DailyMed search for lixisenatide on 14 October 2026 returned a single label — Soliqua's. In practice, lixisenatide reaches US patients inside this insulin pen. Lixisenatide's own heart-outcome trial, ELIXA, enrolled 6,068 people who had recently had an acute coronary syndrome: major cardiovascular events occurred in 13.4% on lixisenatide against 13.2% on placebo (hazard ratio 1.02, 95% CI 0.89 to 1.17). That showed it did not raise cardiovascular risk, but not that it lowered it (Pfeffer et al., NEJM 2015). Semaglutide, liraglutide and dulaglutide later gained heart-protection claims; lixisenatide did not.

The two trials on the label

The label rests on two 30-week, open-label trials, both designed — in the label's words — "to show the contribution of the GLP-1 component", so the insulin dosing was matched between arms.

HbA1c from the label, section 14; weight from the trial publications (Rosenstock et al., Diabetes Care 2016;39:2026; Aroda et al., Diabetes Care 2016;39:1972), which the label's clinical-studies section does not report.

Three things to read from that table:

• The added drop in HbA1c was modest: 0.3 points over glargine alone in LixiLan-O and 0.5 in LixiLan-L. More people reached an HbA1c under 7% on Soliqua (74% against 59% and 33% in LixiLan-O).
• Weight barely moved. The pen's effect on weight was to cancel most of the gain insulin brings — a 1.4 kg difference in both trials — not to produce weight loss. Lixisenatide alone did better on weight (-2.3 kg) but worse on blood sugar.
• The final doses were moderate: a mean 39.8 units (13.1 mcg lixisenatide) at week 30 in LixiLan-O and 46.7 units (15.6 mcg) in LixiLan-L.

A registry number that does not resolve. The label gives LixiLan-O's registration as NCT05058147. ClinicalTrials.gov has no record under that number. The trial's actual record — "Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin", acronym LixiLan-O, 1,170 participants — is NCT02058147, one digit different. LixiLan-L's number on the label, NCT02058160, resolves correctly. Anyone checking the label against the registry should use NCT02058147.

Side effects

The pooled table covers 834 people on Soliqua across both trials, with a mean of 203 days on treatment:

The label describes low blood sugar as the most commonly observed reaction with any insulin-containing product and declines to compare its rates across products, because they depend on how hypoglycaemia was defined and on the background treatment. It is the reaction that most separates Soliqua from a GLP-1-only drug. Nausea was lower than with lixisenatide alone: 9.6% against 24% in LixiLan-O (vomiting 3.2% against 6.4%), as reported in the trial publication. The label's warnings also cover pancreatitis, low potassium, kidney injury from dehydration, gallbladder disease, severe allergic reactions and aspiration under anaesthesia — the last shared with every GLP-1 label (see GLP-1 drugs and surgery).

Soliqua against the GLP-1-only drugs

Novo Nordisk sells the equivalent pairing — insulin degludec with liraglutide — as Xultophy 100/3.6, still listed by FDA as a prescription product. No trial has compared Soliqua with Xultophy directly. For the GLP-1-only options in type 2 diabetes see Ozempic for type 2 diabetes and Trulicity; for every molecule in the class, which drugs are GLP-1s.

What is not established

• Weight loss as a treatment goal. Soliqua was never tested or approved for it.
• Price. Sanofi's current list price was not quoted here; insurance coverage varies by plan.
• Head-to-head results against Xultophy or against a GLP-1 drug added to separate basal insulin.

Whether a combination pen, separate insulin and GLP-1 injections, or neither suits a given person is a decision for their diabetes clinician.

Sources

• SOLIQUA 100/33 (insulin glargine and lixisenatide) injection, Sanofi-Aventis U.S., label effective 2026-03-18, version 25 (set ID 4bba538b-cf7c-4310-ae8f-cb711ed21bcc), sections 1, 2, 3, 6.1, 11 and 14, dailymed.nlm.nih.gov, read 2026-10-14.
• FDA Drugs@FDA, BLA 208673 (Soliqua 100/33), BLA 208471 (Adlyxin), BLA 208583 (Xultophy 100/3.6), via openFDA, read 2026-10-14; DailyMed search "lixisenatide", one result, 2026-10-14.
• ClinicalTrials.gov: NCT05058147 (not found), NCT02058147 (LixiLan-O), NCT02058160 (LixiLan-L), read 2026-10-14.
• Rosenstock J et al. LixiLan-O. Diabetes Care 2016;39:2026-2035, PubMed 27527848; Aroda VR et al. LixiLan-L. Diabetes Care 2016;39:1972-1980, PubMed 27650977.
• Pfeffer MA et al. "Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome." NEJM 2015;373:2247-57, PubMed 26630143.