An FDA approved antidiabetic medication has shown promise in weight reduction among overweight and obese patients.
Data from a phase 3 clinical trial, published in the Nature medicine journal has revealed that the drug tirzepatide provides significant additional weight reduction in patients who have achieved > 5% with intensive lifestyle intervention.
The drug saw a body weight drop of up to -26.6% in patients who had received a maximum tolerable dose (10mg or 15mg) once weekly for 72 weeks.
In comparison, patients who were given a placebo for the same duration of time only had a -3.8% weight reduction.
What is tirzepatide?
Prof. Thomas Wadden (author in the study) states that despite tirzepatide being a single molecule, it is able to combine both glucose-dependent insulinotropic and GLP-1 receptor antagonistic effects. This exerts synergistic effects on appetite, energy intake and metabolic function.
“ In the SURMOUNT-1 trial (phase 1), obese or overweight patients who received tirzepatide 15 mg, with monthly brief lifestyle counseling, lost 20.9% of baseline weight at 72 weeks (versus 3.1% for placebo)”
Nature medicine Journal
Tirzepatide has been approved in the USA, Europe and Japan as a once weekly subcutaneous injection in the management of type 2 diabetes mellitus. It is currently under review for chronic weight management.
Clinical trial findings
The Phase 3 study sponsored by Eli Lily and company, included a total of 579 participants who met the inclusion criteria.
The research team recruited adults (over 18 years of age), who had obesity (>30kg/m2) or were overweight (>27mg/m2) and had at least one weight related complication (excluding diabetes).
Participants qualified by having undergone a 12-week intensive lifestyle intervention that comprised a reduced calorie intake, physical activity and behavioral counselling on lifestyle modification.
The study indicates that the total change in BMI with intensive lifestyle intervention followed by 72 weeks of tirzepatide was −10.4 kg/m2 compared with –1.4 kg/m2 with intensive lifestyle intervention followed by placebo.
The drug also demonstrated an improvement against cardiometabolic risk factors; reduced both diastolic and systolic blood pressure, improved fasting lipid profiles, improved glycemic control as well as fasting insulin levels.
In terms of safety, according to the study, tirzepatide is fundamentally well tolerated. However, gastrointestinal adverse events including nausea, diarrhea and constipation were reported among the participants.