"Nuclear weapons" in the field of weight loss! Tirzepatide is FDA fast-track qualified for obesity treatment

Tirzepatide has recently been granted the U.
S.
Food and Drug Administration (FDA) Fast-Track Qualification for the treatment of obesity or overweight in adults and weight-related comorbidities, meaning that weight loss treatment is about to usher in a new weapon
.

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

For the treatment of obesity, "double agonists" bring more possibilities!

Obesity is the most common chronic disease worldwide, affecting about 650 million adults
.
Currently, some clinical guidelines recommend the use
of antiobesity drugs in obese patients or patients with overweight and weight-related complications.

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

Theoretically, bireceptor agonists combined with GIP and GLP-1 may have greater weight loss effects, and 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
between December 2019 and April 2022 at 119 centers in nine countries.

72 weeks, 48 pounds of weight loss!

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

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

➤5 mg 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 to −1.
9).

Figure 1 Weight change in different Tirzepatide dose groups

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

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

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

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

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

Figure 2 Weight loss effect of different tirzepatide dosage groups

Cardiovascular and metabolic risk factors improved!

While weight loss was lost in the Tirzepatide group compared with placebo, there were greater improvements
in all measured cardiovascular and metabolic risk factors, including lumbar circumference, systolic and diastolic blood pressure, fasting insulin, blood lipids, and aspartate aminotransferase levels.

In addition, almost all participants (>95%) who received Tirzepatide treatment who had prediabetes at the time of baseline examination had turned to normal blood glucose at the end of the main trial period, compared to 62% of participants who received placebo (Table 1).

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

Table 1 Improvement in 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, similar
to other enterologic drugs that treat obesity.

➤ The most common adverse events were the gastrointestinal tract (nausea, diarrhea, and constipation), most of which were mild to moderate
.

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

➤ The incidence of cholelithiasis was similar between the two groups compared to the placebo group, with cholecystitis and acute cholecystitis reported more frequently and the overall incidence was low (≤0.
6%)
.

Tirzepatide is FDA fast-track qualified

In order to meet the current treatment needs of obese patients who cannot meet expectations through diet and exercise treatment, the FDA has approved the Tirzepatide Fast Track qualification, 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 unmet clinical needs, and to make these drugs more quickly applied to the clinic by accelerating the process of drug
review.

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

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