FDA Approves Once-Daily Wegovy Pill as the First Oral GLP-1 Medicine for Weight Loss in Adults With Obesity or Overweight

Wegovy (semaglutide) is a prescription medicine that helps with weight loss and lowers the risk of heart problems and liver disease. The FDA has approved its oral pill form to be used alongside a low-calorie diet and increased physical activity to help adults with obesity, or those who are overweight with weight-related medical conditions, lose weight and keep it off. Wegovy tablets are also approved to reduce the risk of major adverse cardiovascular events (MACE), such as heart attacks, strokes, or death, in adults with heart disease who have obesity or are overweight.

Obesity is a common, long-term, and serious health condition that develops over time and can be challenging to manage. It raises your risk of heart disease, stroke, type 2 diabetes, and liver disease. Obesity may be shaped by a person’s genes, living conditions, and environment. But many biological factors influence a person’s ability to lose weight and maintain the weight loss in the long run.

Wegovy is a type of medicine called a glucagon-like peptide-1 (GLP-1) receptor agonist, which works by acting like a natural hormone known as GLP-1. It attaches to the same receptors in your brain that GLP-1 normally uses for regulating your blood sugar and controlling how much food you eat. By mimicking its action, Wegovy can help you feel full sooner, making it easier for you to control your appetite and eat less.

First approved in 2017, Wegovy was available only as a weekly injection until now. This approval matters because it’s the first time a GLP-1 medicine has been approved in pill form for weight management in the U.S., providing a convenient alternative for those who prefer taking a pill instead of getting a shot. It will also help more people start or continue with their weight loss plans.

Why Was It Approved?

The FDA approved the once-daily Wegovy pill because studies showed that it was safe, well tolerated, and as effective as its injectable version in helping people lose excess weight when used along with lifestyle changes.

A 64-week phase III clinical trial studied the safety and effectiveness of a once-daily Wegovy pill compared with a placebo in 307 adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related health condition (except diabetes). People in the study were randomly assigned in a 2:1 ratio to receive the Wegovy pill or a placebo once daily, along with a low-calorie diet and exercise support. Results showed meaningful weight loss with the Wegovy pill. Patients who stayed on treatment lost about 17% of their body weight on average, compared with about 3% in those receiving a placebo. When all people in the study were included, even if they did not stay on treatment the entire time, average weight loss was still about 14% with the Wegovy pill vs. about 2% with the placebo. And 76% of people taking the Wegovy pill achieved at least a 5% weight loss, compared with 31% of those receiving a placebo.

The most common side effects included nausea, diarrhea, vomiting, constipation, stomach pain, headache, tiredness, indigestion, dizziness, bloating, belching or burping, gas, stomach or intestinal infection, acid reflux, and common cold-like symptoms. Low blood sugar may also happen in patients with type 2 diabetes.

What Do I Need to Know?

Wegovy comes in two forms: a daily pill and a weekly shot. If you take the pill, you should do so in the morning on an empty stomach with a small amount of water – no more than 4 ounces. Do not take Wegovy tablets with any other liquids except water. After taking it, wait at least 30 minutes before eating, drinking, or taking any other oral medicines. Swallow the Wegovy tablets whole, without splitting, crushing, chewing, or dissolving them. If you miss a dose, skip it and take your next dose as scheduled. Follow the dose recommended by your health care provider, as taking too much can cause severe vomiting, diarrhea, and dangerously low blood sugar. The medicine is meant to be used along with a low-calorie diet and a more physically active lifestyle.

You should not use Wegovy if you or someone in your family has had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2). It is not known whether Wegovy causes thyroid tumors or MTC in people. Tell your health care provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these could be signs of thyroid cancer.

Let your health care provider know if you have had pancreatitis, gallbladder disease, stomach issues, kidney problems, type 2 diabetes, or an allergic reaction to Wegovy or any of its ingredients. Your health care provider will check your blood sugar before starting and during your treatment. Inform your health care provider about taking Wegovy before having any surgery or procedures that use anesthesia or deep sleepiness.

Since Wegovy slows how quickly your stomach empties, it can affect how other medicines are absorbed. Be sure to inform your health care provider about all the medicines you take, including over-the-counter products, vitamins, herbal remedies, and health supplements – especially if you use insulin or other diabetes medicines. Do not use Wegovy with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

Wegovy is not recommended if you are pregnant or breastfeeding. If you plan to become pregnant, stop using Wegovy at least two months before trying to conceive. Always talk to your health care provider to see if Wegovy is a good fit for your health needs.

Contact your health care provider at once if you have severe pain in your stomach area (abdomen); nausea, vomiting, or diarrhea that will not go away; dark urine; yellowing of your skin or eyes; vision or eye problems; an irregular heartbeat; swelling of your face, lips, tongue, or throat; a severe rash or itching; or sudden changes in your mood, behaviors, thoughts, or feelings. These could be signs of serious side effects. Your health care provider will guide you on how to watch for signs and symptoms of low blood sugar and manage them.