Losing weight will welcome new weapons! Tirzepatide is FDA Express Track status

According to the results of the SURMOUNT-1 study published at the American Diabetes Association's Scientific Meeting (ADA), in the non-diabetic overweight/obese adult population, at 72 weeks, the Tirzepatide highest-dose group (15mg) lost an average of 48 pounds, and the weight loss effect was comparable to surgery
.

To treat obesity, "dual agonists" bring more possibilities!

Obesity is the most common chronic disease worldwide, affecting an estimated 650 million adults
.
Currently, some clinical guidelines recommend the use of anti-obesity drugs for obese patients or those with overweight and weight-related complications
.

Tirzepatide injection is a novel glucagon-like peptide-1 receptor-1 receptor (GLP-1) and glucose-dependent insulin stimulating peptide (GIP) dual receptor tract agonist, approved by the US Food and Drug Administration (FDA) in May 2022 for the treatment of type 2 diabetes
.

To understand their efficacy and safety in obese people, the researchers designed the "SURMOUNT-1 study," a phase 3, double-blind, randomized, controlled, multicenter trial conducted at 119 centers in nine countries from December 2019 to April 2022
.

72 weeks, weight loss of 48 pounds!

A total of 2,539 adults (mean age 44.
9 years) with a body mass index (BMI) ≥of 30 kg/m^2 or ≥27 kg/m^2
were enrolled in the study with at least one obesity complication (excluding diabetes).
All participants received subcutaneous injection of Tirzepatide (5 mg, 10 mg, or 15 mg) or placebo once a week in a 1:1:1:1 ratio for 72 weeks
.
The primary endpoints were percentage change in body weight and proportion of at least 5% weight loss
.
The results of the study are as follows:

Average change in BMI at 72 weeks (Figure 1):

➤5mg group: −15.
0% (95% CI, −15.
9~−14.
2);

➤10mg group: −19.
5% (95% CI, −20.
4~−18.
5);

➤15mg group: −20.
9% (95% CI, −21.
8~−19.
9);

➤ Placebo group: −3.
1% (95% CI, −4.
3~−1.
9).

Fig.
1 Weight change in different Tirzepatide dose groups

Weight loss in each dose group at 72 weeks (Figure 2):

➤5mg group: weight loss of 16.
1kg, (95% CI, −16.
8~−15.
2)

➤10mg group: weight loss of 22.
2 kg, (95% CI, −22.
2~−20.
6)

➤15mg group: weight loss of 23.
6 kg, (95% CI, −23.
3~−21.
7)

➤ Placebo group: weight loss of 2.
4kg, (95% CI, −3.
2~−1.
6).

Fig.
2 Weight loss effect of different tirzepatide dose groups

Cardiovascular and metabolic risk factors improved!

Weight loss in the Tirzepatide group was associated with greater improvements
in all measured cardiovascular and metabolic risk factors, including waist circumference, systolic and diastolic blood pressure, fasting insulin, lipids, and aspartate aminotransferase levels.

In addition, almost all participants treated with Tirzepatide (>95%) who had prediabetes at baseline had become normoglycaemic at the end of the main trial period, compared to 62% of participants treated with placebo (Table 1).

These improvements may reduce the risk of cardiovascular disease, chronic kidney disease, nonalcoholic fatty liver disease, and type 2 diabetes, among other outcomes
.

Table 1 Improvement of cardiovascular and metabolic risk factors

How secure is Tirzepatide?

The safety profile of Tirzepatide is consistent with previous findings in clinical trials in patients with type 2 diabetes and is similar
to other enterocin-based drugs used to treat obesity.

➤ The most common adverse events were gastrointestinal (nausea, diarrhoea and constipation), mostly mild to moderate
.

➤ Four confirmed cases of pancreatitis were reported, evenly distributed across treatment and placebo groups
.

➤ Compared with placebo, the incidence of cholelithiasis was similar between groups, cholecystitis and acute cholecystitis were reported more frequently in the treatment group, and the overall incidence was low (≤0.
6%)
.

Tirzepatide is FDA Fast Track designated

In order to meet the treatment needs of obese patients who cannot meet the expectations through diet and exercise, the FDA approved the Tirzepatide Fast Track approval process, which is one of the four special approval procedures of the FDA, which aims to promote the development of drugs for the treatment of major diseases or drugs that do not meet clinical needs, and enable these drugs to reach patients earlier by speeding up the drug review process
.

Tirzepatide's fast-track review process means there will be more options
for weight loss treatment in the near future.

Source: Jill Rollet.
FDA grants fast track designation to tirzepatide to treat obesity, overweight[EB/OL].
[2022-10-08].