FDA Approves New Weight Management Drug Zepbound
The U.S. Food and Drug Administration (FDA) has announced the approval of Zepbound (tirzepatide) for chronic weight management in adults, signifying a pivotal step in the treatment of obesity and overweight. Specifically targeting individuals with a body mass index (BMI) of 30 kg/m2 or greater, or those with a BMI of 27 kg/m2 or greater who also suffer from related conditions such as high blood pressure, type 2 diabetes, or high cholesterol, Zepbound is to be used alongside a reduced-calorie diet and increased physical activity for optimal efficacy.
Background on Tirzepatide
Previously approved under the trade name Mounjaro for the improvement of blood sugar levels in conjunction with dietary and exercise regimes in adults with type 2 diabetes, tirzepatide is now set to combat weight-related health issues as the active ingredient in Zepbound.
Statement from the FDA
John Sharretts, M.D., leading the Division of Diabetes, Lipid Disorders, and Obesity within the FDA’s Center for Drug Evaluation and Research, highlights the criticality of Zepbound's approval amidst the escalating prevalence of obesity and overweight in the United States. Such conditions are linked with some of the most common causes of death, including heart disease, stroke, and diabetes.
Obesity and Overweight in the U.S.
Statistics suggest that around 70% of American adults fall into the category of obesity or overweight, with a considerable number facing weight-related health challenges. Studies advocate that reducing body weight by 5% to 10% through dietary and physical activity modifications can notably diminish the risk of cardiovascular diseases in this population.
Mechanism of Action
The drug operates by engaging receptors for intestine-secreted hormones such as Glucagon-Like Peptide-1 (GLP-1) and Glucose-Dependent Insulinotropic Polypeptide (GIP). By doing so, it effectively diminishes appetite and subsequently food intake. Administered via subcutaneous injection on a weekly basis, the dosage of Zepbound is escalated progressively, reaching target doses of 5 mg, 10 mg, or 15 mg.
Clinical Trials and Effectiveness
The efficacy of Zepbound in the realm of chronic weight management has been substantiated through two rigorous randomized, double-blind, placebo-controlled trials, involving a total of 3,477 patients. Post 72 weeks of treatment, those administered Zepbound exhibited substantial weight loss as opposed to their placebo-receiving counterparts, with a larger proportion achieving a minimum of 5% weight loss.
Results from Clinical Trials
In the most extensive non-diabetic adult trial, with an average initial weight of 231 pounds and BMI of 38 kg/m2, the highest dose of Zepbound yielded an average weight reduction of 18%. In contrast, a trial focusing on adults with type 2 diabetes commenced with average weights of 222 pounds and a BMI of 36 kg/m2; here, the highest dose of Zepbound led to an average weight loss of 12%.
Side Effects and Warnings
Zepbound administration can lead to adverse effects such as nausea, diarrhea, vomiting, constipation, abdominal discomforts, and hypersensitive reactions. Furthermore, the occurrence of thyroid C-cell tumors in rat studies raises concerns, although the transference of this risk to humans remains unconfirmed. Its use is thus contraindicated in individuals with a history of specific thyroid cancers or Multiple Endocrine Neoplasia syndrome type 2.
Patients with a history of severe gastrointestinal conditions or pancreatitis, as well as those currently on GLP-1 receptor agonists, should refrain from Zepbound use. The drug's labeling also cautions against potential pancreatitis, gallbladder issues, hypoglycemia, kidney damage, diabetic retinopathy, and thoughts or behaviors of suicide.
Approvals and Designations
The approval honor falls to pharmaceutical innovator Eli Lilly and Co., marking another milestone in their distinguished history.
- W8MD weight loss centers is one of the first weight loss centers in the United States to announce offering Zepbound injections for weight loss, as soon as they are available.
Transform Your Life with W8MD Weight Loss Centers
Ready to Shed Those Extra Pounds?
Experience the power of transformation with W8MD!
Discover our convenient locations:
- Address: 1718 Welsh Road, 2nd Floor, Ste C, Philadelphia, PA 19115
- Phone: (215) 676-2334
- Address: 175 Strafford Ave, Ste 1, Wayne, PA 19087
- Address: 2632 E 21st Street Ste L3, Brooklyn, New York 11235
- Phone: (718) 946-5500
Why Choose W8MD?
Transform your life with W8MD's Physician Weight Loss program:
- Expert Doctors
- Accepting Most Insurances
- Convenient Telemedicine Options
- Inspiring Weight Loss Success Stories
- FDA-Approved Weight loss medications including new weight loss injections such as Wegovy, Ozempic, Mounjaro, Zepbound, Saxenda etc, both brand and generic when available.
Tele-weight loss options
Live far and cannot come to the office? We do offer convenient tele weight loss options!
Book Your Appointment
Ready to take the first step towards a healthier you? Book your appointment today:
|External Resources & AI tools|
|Up To Date|
WikiMD is the world's largest, free medical and wellness encyclopedia edited only by professionals. Advertise!
Contributors: Prab R. Tumpati, MD