Lilly Introduces Zepbound Single-Dose Vial for Cash-Paying Patients

Lilly has released a single-dose vial version of Zepbound (tirzepatide) for self-pay patients. The single-dose is available in 2.5 mg and 5 mg doses.

Zepbound is used to treat adults who are obese as measured by body mass index or those who are overweight and have high blood pressure, diabetes, or high cholesterol. Tirzepatide is also available with the name Mounjaro to treat adults with type 2 diabetes.

Zepbound activates receptors of hormones secreted from the intestine — glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) — to reduce appetite and food intake.

“In a clinical study, the 5 mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA, said in a news release.

A four-week supply of the 2.5 mg Zepbound single-dose vial is $399 ($99.75 per vial), and a four-week supply of the 5 mg dose is $549 ($137.25 per vial). Lilly officials said this price is in line with the Zepbound savings program for non-covered patients. Lilly created the self-pay pharmacy component of LillyDirect where patients with a valid prescription can purchase Zepbound.

Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 ml doses in a single-dose pen. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.

Zepbound launched in the United States to treat adult patients with obesity or overweight with weight-related comorbidities in November 2023. For the first six months of 2024, Zepbound generated sales of $1.76 billion

Last week, Lilly released data from the SURMOUNT-1 three-year study, which found that tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or who are overweight. Tirzepatide resulted in sustained weight loss through the treatment period, averaging a 22.9% decrease in body weight with the 15 mg.

Tirzepatide was evaluated in 1,032 adults who had pre-diabetes at randomization and obesity or overweight for a treatment period of 176 weeks, followed by a 17-week off-treatment period (193 weeks in total).

In a secondary endpoint, tirzepatide (10 mg and 15 mg) led to statistically significant weight reduction compared with placebo in adults with pre-diabetes and obesity or overweight from baseline to week 176.

During the 17-week off-treatment follow-up period, those who had discontinued from tirzepatide began to regain weight and had some increase in the progression to type 2 diabetes, resulting in an 88% reduction in the risk of progression to type 2 diabetes compared with placebo.

Results from the SURMOUNT-1 phase 3 study’s primary analysis at 72 weeks in all participants were published in the New England Journal of Medicine in 2022.

Lilly has submitted tirzepatide to regulatory authorities in the United States and the EU to treat adult patients with moderate-to-severe obstructive sleep apnea with obesity. Data released in June 2024 show tirzepatide reduced moderate-to-severe obstructive sleep apnea severity by up to 62.8%. In a key secondary endpoint from two clinical studies, 43.0% and 51.5% of participants taking tirzepatide at the highest dose reached the criteria for disease resolution as defined by apnea-hypopnea index and Epworth Sleepiness Scale measures.

Lilly continues research of tirzepatide for other diseases. Earlier this month, Lilly released data from the SUMMIT phase 3 trial showing that tirzepatide reduced the risk of heart failure outcomes – heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death – by 38% compared with placebo.

In metabolic dysfunction-associated steatohepatitis (MASH) — also known as nonalcoholic steatohepatitis (NASH) — a phase 2 trial of three different doses of tirzepatide resulted in resolution of the disease and more than half of patients achieved improvement in fibrosis at 52 weeks, according to results released in June 2024.

These data were presented at the European Association for the Study of the Liver (EASL) Congress 2024 and published in The New England Journal of Medicine.

MASH is a more advanced form of nonalcoholic fatty liver disease (NAFLD), which is estimated to affect about 30% adults in the United States. It is a leading cause of liver-related mortality, especially for those with more advanced metabolic risk factors such as hypertension and type 2 diabetes.