At the 15mg dose, participants showed a sustained average weight loss of 22.9% during the three-year treatment. Credit: SB Arts Media / Shutterstock.

Eli Lilly has reported comprehensive outcomes from the SURMOUNT-1 study of tirzepatide (Zepbound and Mounjaro) for treating pre-diabetic and obese individuals.

Spanning 176 weeks of treatment, the Phase III trial evaluated the efficacy and safety of tirzepatide in adults without type 2 diabetes (T2D) who were either obese or overweight with complications such as cardiovascular disease, dyslipidaemia, hypertension, obstructive or sleep apnoea (OSA).

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The randomised, multi-centre, placebo-controlled, double-blind, parallel, placebo-controlled trial included 1,032 pre-diabetic individuals.

These participants continued treatment for an additional 104 weeks after the initial 72-week period to assess the impact on body weight and progression to T2D.

Tirzepatide, administered weekly via injection, significantly ‘decreased’ the risk of developing T2D compared to placebo over 176 weeks.

At the highest 15mg dose, participants showed sustained average weight loss of 22.9% during the three-year treatment.

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A 94% decrease is also observed in the T2D progression risk versus placebo over three years.

The dual glucagon-like peptide-1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide (GIP) is the only approved medicine of its kind and works by mimicking incretin hormones, which are crucial for the incretin effect following nutrient intake.

Further findings from the study indicated improvements in glycaemic control, cardiometabolic risk factors, and health-related quality of life associated with the therapy treatment.

Eli Lilly product development senior vice-president Jeff Emmick said: “In the SURMOUNT-1 three-year study of tirzepatide, an average weight reduction of up to 22.9% was accompanied by a hazard ratio of 0.06 for progression to type 2 diabetes.

“This translates to a risk reduction of 94% and a number needed to treat nine to prevent one case of diabetes.

“These results underscore the critical role of long-term therapy with effective treatments like tirzepatide to achieve and maintain weight reduction.”  

The safety profile of tirzepatide, observed over 193 weeks, remained consistent in line with the previous outcomes.

In June 2024, the company reported data from the Phase II SYNERGY-NASH trial of tirzepatide in adult patients with metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 or 3 fibrosis.