US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has released 176-week follow-up data from its Phase III SURMOUNT-1 study for tirzepatide, marking the longest completed study to date for the dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. This data provides significant insights into the drug’s long-term efficacy and safety.
Study Design and Participants
The multi-center, randomized, double-blinded, placebo-controlled Phase III study evaluated the efficacy and safety of tirzepatide in various doses (5 mg, 10 mg, and 15 mg) compared with a placebo. The study focused on adults without type 2 diabetes who had obesity or were overweight with comorbidities such as hypertension, dyslipidemia, obstructive sleep apnea (OSA), or cardiovascular disease. Participants who had pre-diabetes at the start of the study continued for an additional 104 weeks of treatment after the initial 72-week period, assessing the impact on body weight and potential differences in progression to type 2 diabetes.
Significant Findings
The data over 176 weeks demonstrated that subjects receiving weekly tirzepatide injections experienced sustained average weight loss of 22.9% with the 15 mg dose throughout the three-year treatment period, significantly outperforming the placebo. Additionally, tirzepatide showed a 94% reduction in the risk of progression to type 2 diabetes across all pooled doses. The drug also improved other endpoints, including blood glucose control, cardiovascular metabolic risk factors, and health-related quality of life, significantly better than the placebo.
Safety and Tolerability
At 193 weeks (176 weeks of treatment followed by 17 weeks off-treatment), the overall safety and tolerability profile of tirzepatide remained consistent with previous findings, indicating the drug’s long-term safety.
Regulatory Approvals and Development
Tirzepatide was first approved by the U.S. FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control in May 2022. It later received approval as Zepbound for long-term weight management in November 2023. Eli Lilly is also developing tirzepatide for the treatment of heart failure and metabolic dysfunction associated with steatohepatitis (MASH), among other conditions.-Fineline Info & Tech
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