Lilly has introduced a single-dose vial option for its medication Zepbound (tirzepatide) aimed at self-pay patients. This new version comes in doses of 2.5 mg and 5 mg.
Zepbound is prescribed for adults struggling with obesity, as indicated by their body mass index, or for those who are overweight and have associated health issues like high blood pressure, diabetes, or high cholesterol. Tirzepatide is also marketed as Mounjaro for managing type 2 diabetes in adults.
The drug works by activating hormone receptors in the intestine—specifically glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)—which help suppress appetite and lower food intake.
Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, remarked, “In a clinical study, the 5 mg maintenance dose helped patients achieve an average weight loss of 15% after 72 weeks of treatment and has proven to be an effective resource for millions aiming to lose weight sustainably.”
The pricing for the vial versions is set at $399 for a four-week supply of the 2.5 mg dose ($99.75 per vial) and $549 for the 5 mg option ($137.25 per vial). Lilly maintains that these prices align with the savings program offered for patients without insurance coverage. LillyDirect now allows patients with a valid prescription to purchase Zepbound via a self-pay pharmacy model.
Zepbound is also offered in various doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg) using a single-dose pen, with recommended maintenance doses of 5 mg, 10 mg, or 15 mg administered subcutaneously on a weekly basis.
Since its launch in the U.S. in November 2023, which targeted adult patients dealing with obesity or relevant weight-related conditions, Zepbound has generated sales of $1.76 billion in its first six months.
Recently, Lilly published findings from the long-term SURMOUNT-1 study, which indicated that tirzepatide reduces the likelihood of developing type 2 diabetes by 94% among adults with pre-diabetes and obesity or those who are overweight. The study noted that subjects experienced an average weight reduction of 22.9% during a 176-week treatment period.
The trial involved 1,032 adults diagnosed with pre-diabetes and overweight or obesity and included a 17-week period without treatment following the initial phase.
Further analysis revealed that individuals receiving tirzepatide at doses of 10 mg and 15 mg experienced significant weight loss in comparison to the placebo group, particularly through to week 176. During the follow-up period without medication, patients who stopped taking tirzepatide began to regain weight and showed an increased risk of developing type 2 diabetes, with the overall risk of progression lowered by 88% compared to those on placebo.
The primary analysis findings from the SURMOUNT-1 phase 3 trial, which were released in the New England Journal of Medicine in 2022, provided a comprehensive overview of these results.
Lilly has also submitted tirzepatide for regulatory review in the U.S. and EU for the treatment of adults with moderate-to-severe obstructive sleep apnea associated with obesity. Preliminary data from June 2024 indicated a reduction in obstructive sleep apnea severity by 62.8%, with significant proportions of participants at the highest dose meeting criteria for disease resolution based on established metrics.
Further research is ongoing for tirzepatide’s potential in treating other disorders. Recent data from the SUMMIT phase 3 trial demonstrated a 38% reduction in heart failure risks associated with tirzepatide compared to placebo.
Moreover, a phase 2 trial for metabolic dysfunction-associated steatohepatitis (MASH) demonstrated promising results, with significant improvements in disease resolution and fibrosis among participants after 52 weeks, highlighting tirzepatide’s multifaceted benefits.
MASH, a severe form of nonalcoholic fatty liver disease (NAFLD), is estimated to affect about 30% of adults in the U.S. and poses a significant mortality risk, particularly among those with heightened metabolic risk factors.