Tirzepatide achieved significant weight loss in adults with obesity and type 2 diabetes, study shows

Eli Lilly and Company has announced that tirzepatide (10 mg once-weekly and 15 mg once-weekly) achieved superior weight loss compared to placebo at 72 weeks of treatment, according to results from SURMOUNT-2.

The study met both co-primary objectives and all key secondary objectives for tirzepatide compared to placebo for both estimands.

Those taking tirzepatide lost up to 15.7 per cent (34.4 lb. or 15.6 kg) of body weight for the efficacy estimand.

SURMOUNT-2 is the second global phase 3 clinical trial that evaluated the efficacy and safety of tirzepatide for chronic weight management. The trial evaluated 938 adult participants with obesity or overweight and type 2 diabetes.

Dr Kunal Gulati, Executive Director Diabetes Medical Affairs, Lilly Northern Europe, said: “Obesity is a difficult to manage disease, and it’s even more difficult for people living with type 2 diabetes.

“The data from SURMOUNT-2 show that trial participants achieved average weight reductions of 13.4 per cent on tirzepatide 10 mg and 15.7 per cent on 15 mg compared to 3.3 per cent on placebo.”

Dr Gulati added: “Preventing obesity is a key focus but it’s also vitally important that we continue to develop future treatments for obesity.

“Lilly is committed to developing innovative solutions to help people living with obesity, and will continue to work with regulators, the health service and other agencies, so that people in the UK can benefit from treatments as they become available.”

For the efficacy estimand, participants taking tirzepatide achieved average weight reductions of 13.4 per cent (29.8 lb. or 13.5 kg) on 10 mg once-weekly and 15.7 per cent (34.4 lb. or 15.6 kg) on 15 mg once-weekly compared to placebo (3.3%, 7.0 lb. or 3.2 kg).

Additionally, 81.6 per cent (10 mg) and 86.4 per cent (15 mg) of people taking tirzepatide achieved at least five per cent body weight reduction, the other co-primary endpoint, compared to 30.5 per cent of those taking placebo.

Tirzepatide also met all key secondary objectives, which included reduction in HbA1C and other cardiometabolic parameters.

Approximately 41.4 per cent (10 mg) and 51.8 per cent (15 mg) of people taking tirzepatide achieved at least 15 per cent body weight reduction compared to 2.6 per cent of those taking placebo.

Reduction in HbA1C compared to placebo was similar to the SURPASS trials in adults with type 2 diabetes.

Study participants had a mean baseline body weight of 222 lb. (100.7 kg) and baseline HbA1C of eight per cent.

For the treatment-regimen estimand, results showed:

• Average body weight reductions: 12.8 per cent (10 mg), 14.7 per cent (15 mg), 3.2 per cent (placebo)
• Percentage of participants achieving body weight reductions of ≥5%: 79.2 per cent (10 mg), 82.7 per cent(15 mg), 32.5 per cent (placebo)
• Percentage of participants achieving body weight reductions of ≥15 per cent: 39.7 per cent (10 mg), 48.0 per cent (15 mg), 2.7 per cent (placebo)

The overall safety profile of tirzepatide was similar to previously reported SURMOUNT and SURPASS trials and to incretin-based therapies approved for the treatment of obesity and overweight.

The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, usually occurring during the dose-escalation period.

For those treated with tirzepatide (10 mg and 15 mg, respectively), nausea (20.2 per cent, 21.9 per cent), diarrhoea (19.9 per cent, 21.5 per cent), vomiting (10.9 per cent, 13.2 per cent) and constipation (8.0 per cent, 9.0 per cent) were more frequently reported compared to placebo (6.3 per cent [nausea], 8.9 per cent [diarrhoea], 3.2 per cent [vomiting], 4.1 per cent [constipation].

Treatment discontinuation rates due to adverse events were 3.8 per cent (10 mg), 7.4 per cent (15 mg) and 3.8 per cent (placebo).

The overall treatment discontinuation rates were 9.3 per cent (10 mg), 13.8 per cent (15 mg) and 14.9 per cent (placebo).

Lilly will continue to evaluate the SURMOUNT-2 results, which will be presented at the American Diabetes Association’s 83rd Scientific Sessions and submitted to a peer-reviewed journal.

Based on these results, Lilly plans to complete the US submission for tirzepatide in adults with obesity or overweight with weight-related comorbidities in the coming weeks and UK submission will follow.

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