Obesity is a condition in which excess body fat can lead to various health problems, including heart disease, stroke, type 2 diabetes, certain cancers, and sleep apnea. In addition to physical health problems, obesity can also lead to mental health problems, such as depression and anxiety.
Obesity treatment typically involves lifestyle changes, such as increased physical activity and improved diet, and medical interventions, such as weight loss medication or bariatric surgery. However, long-term weight loss can be challenging, and many struggle to maintain weight loss over time. There is an urgent need for safe and effective treatments to help people with obesity achieve and maintain weight loss.
In a clinical trial, researchers investigated the efficacy and safety of a novel medication, tirzepatide, in adults with obesity. Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that increases insulin secretion, reduces glucagon secretion, and suppresses appetite. GIP and GLP-1 are called ‘incretin’ hormones, which play crucial roles in regulating metabolism. Tirzepatide is approved for treating type 2 diabetes in the USA, Europe, and the UAE.
The study was a double-blind, randomized, controlled trial that involved 2,539 adults with a body-mass index of 30 or more or 27 or more and at least one weight-related complication, excluding diabetes. Participants were randomly assigned to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or a placebo for 72 weeks, including a 20-week dose-escalation period.
Dose escalation is a process in which a medication is gradually increased in dosage over time to minimize the risk of side effects and maximize the therapeutic benefit. It is a common practice in clinical trials to ensure medication's safe and effective use.
Tirzepatide treatment resulted in significant weight loss compared to the placebo. The mean percentage change in weight at week 72 was -15.0% with a 5-mg weekly dose of tirzepatide, -19.5% with a 10-mg dose, and -20.9% with a 15-mg dose, compared to -3.1% with placebo.
The percentage of participants who had a weight reduction of 5% or more was also significantly higher in the tirzepatide groups (85%, 89%, and 91%) compared to the placebo group (35%). Furthermore, 50% and 57% of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, respectively, compared to only 3% in the placebo group.
The study also found improvements in all prespecified cardiometabolic measures with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse events caused treatment discontinuation in a small percentage of participants in each group.
In conclusion, this 72-week trial showed that once-weekly tirzepatide treatment provided substantial and sustained reductions in body weight in adults with obesity. The study's findings suggest that tirzepatide could be a safe and effective treatment option for people with obesity. However, further research is needed to confirm these results and assess long-term safety and efficacy.