Eli Lilly’s tirzepatide met all primary and key secondary objectives in two pivotal Phase III trials in adults with obesity or who have weight-related comorbidities, excluding type 2 diabetes (T2D).
Participants in the SURMOUNT-3 and SURMOUNT-4 trials achieved up to 26.6% mean weight loss when treated with tirzepatide after an intensive lifestyle intervention or with continued tirzepatide treatment.
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The drug retained its safety profile that was reported in previous weight loss and diabetes trials. The most common adverse events were related to the gastrointestinal tract, which was generally mild to moderate in severity.
Tirzepatide targets glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) receptors, which are natural incretin hormones. In May 2022, tirzepatide was approved by the US Food and Drug Administration (FDA) for T2D and marketed as Mounjaro.
The full data from SURMOUNT-3 and SURMOUNT-4 trials will be presented at conferences in October. In April, Lilly announced that tirzepatide met co-primary and major secondary endpoints in the SURMOUNT-2 trial.
SURMOUNT-3 trial data
The SURMOUNT-3 trial (NCT04657016) evaluated the efficacy and safety of tirzepatide for 72 weeks after a 12-week intensive lifestyle intervention lead-in period.
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By GlobalDataThis period included a low-calorie diet, exercise and weekly counselling sessions. At the end of the lead-in period, participants achieved 6.9% mean weight loss.
For the efficacy estimand, treated patients lost an additional 21.1% of their body weight, whereas participants in the placebo cohort regained 3.3% of their mean weight over the 72 weeks. For the treatment-regimen estimand, treated patients lost an additional 18.4% of their body weight, compared to 2.5% mean weight regain in the placebo cohort over 72 weeks.
SURMOUNT-4 trial data
The SURMOUNT-4 trial (NCT04660643) evaluated the safety and efficacy of tirzepatide in a 36-week open-label lead-in period when all participants took the drug, followed by a 52-week double-blind period, which randomised patients to treatment and placebo cohorts.
At the end of the open-label lead-in period, participants achieved 21.1% mean weight loss.
For the efficacy estimand, treated patients lost an additional 6.7% of their body weight, while participants in the placebo cohort regained 14.8% of mean weight at 88 weeks. For the treatment-regimen estimand, treated patients lost an additional 5.5%, whereas the placebo cohort regained 14% of the mean weight.
Recent GLP-1 agonist controversy
In the past few weeks, other GLP-1 receptor agonists such as Novo Nordisk’s semaglutide, sold under the names of Ozempic and Wegovy, have been in a negative media spotlight.
On 27 July, Reuters reported that Novo Nordisk’s factory had breached sterile-safety rules and the staff failed to complete needed quality checks in 2021 and 2022.
Big media outlets also reported that patients who took semaglutide are experiencing side effects such as severe gastroparesis. CNN was the first to report these claims on 25 July.
Earlier this month, the European Medicines Agency (EMA) started to investigate if Novo Nordisk’s semaglutides and Saxenda (liraglutide) can cause thoughts of suicide and self-harm.
