Semaglutide is an injectable drug formulated for the treatment of type 2 diabetes, but it’s since become increasingly popular as a weight loss treatment. While the drug—commonly known by brand names such as Ozempic and Wegovy— helps reduce blood glucose to normal levels, it also slows the passage of food through the stomach and reduces appetite, often resulting in weight reduction.

There are several variations of semaglutide, but only one is Food and Drug Administration (FDA)-approved for weight loss. Keep reading for information about semaglutide’s safety profile, side effects and efficacy.

What Is Semaglutide?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that works by mimicking the activity of GLP-1, a hormone released in the intestine after eating. GLP-1 triggers insulin production, thereby reducing blood sugar levels, and interacts with parts of the brain to decrease hunger and promote feelings of satiety. Different forms of semaglutide are FDA-approved for treating type 2 diabetes or obesity (in conjunction with diet and exercise).

Semaglutide Medications

Semaglutide is the active ingredient in the brand-name medications Ozempic, Wegovy and Rybelsus, says Aleem Kanji, M.D., a board-certified endocrinologist and obesity medicine specialist at Ethos Endocrinology in Houston, Texas. Currently, no generic versions are available.

• Ozempic (injection) is FDA-approved to reduce blood sugar levels in adults with type 2 diabetes. It’s also approved to lower the risk of serious cardiac events such as stroke, heart attack and death in individuals with diabetes and heart disease, says Katherine H. Saunders, M.D., an obesity medicine specialist and co-founder of Intellihealth. Weekly doses range from 0.25 milligrams  to 2 milligrams, she adds.
• Rybesus (tablet) is FDA-approved to lower blood sugar levels in adults diagnosed with type 2 diabetes. It’s taken daily in doses ranging from 3 milligrams to 14 milligrams, says Dr. Saunders.
• Wegovy (injection) is FDA-approved for use in adults and children over the age of 12 who have obesity or who have weight-related health issues such as high cholesterol, type 2 diabetes or high blood pressure, says Dr. Saunders. It’s taken weekly in doses ranging from 0.25 milligrams to 2.4 milligrams, she says.

Although not FDA-approved for weight loss, Ozempic is sometimes prescribed off-label for treating obesity, says Dr. Kanji.

Is Semaglutide Effective for Weight Loss?

“Semaglutide is very effective for weight loss,” says Dr. Saunders. In fact, a 2021 phase 3 clinical trial found that 2.4 milligram weekly semaglutide injections produced a mean weight loss of 14.9% (versus 2.4% with a placebo) after 68 weeks in people with a body mass index (BMI) of 30 or above^[1].

“This [study] led to the FDA’s approval in June 2021 of a once-weekly injectable semaglutide under the brand name Wegovy [for weight management in individuals with overweight and obesity who have at least one weight-related condition],” says Dr. Kanji.

Is Semaglutide Effective for Weight Loss for People Without Diabetes?

“Semaglutide is FDA-approved as Wegovy for chronic weight management in individuals with or without diabetes,” says Dr. Saunders. She adds that oral semaglutide is expected to be FDA-approved for chronic weight management soon.

Who Is a Good Candidate for Semaglutide?

“A good candidate for Ozempic is someone who is comfortable providing a weekly self-injection, has a medical history of type 2 diabetes and an elevated body mass index (BMI) of at least 27,” says Dr. Saunders. Similarly, a good candidate for Rybelsus has a medical history of type 2 diabetes and a body mass index (BMI) of 27 or more, she says.

A good candidate for Wegovy must also be comfortable with a weekly self-injection and have a BMI of 30 (with or without weight-related health complications) or a BMI of at least 27 with at least one weight-related health complication (like high cholesterol or hypertension), explains Dr. Saunders.

Semaglutide Side Effects

Common side effects of semaglutide, according to Dr. Kanji, include:

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Constipation
• Headaches

“Strategies for reducing or managing side effects include a slow titration [which means adjusting the dose], adequate hydration and use of medication for symptom control as needed,” says Dr. Kanji.

Serious adverse effects include:

• Pancreatitis (inflammation of the pancreas)
• Changes in vision
• Low blood sugar
• Kidney problems or kidney failure
• Serious allergic reactions
• Gallbladder problems

If you are taking semaglutide and experience any of the following symptoms, you should reach out to your health care provider immediately or seek emergency medical care:

• Ongoing pain starting in the upper left or middle of the abdomen that spreads to the back, with or without vomiting
• Rash, itchiness, swelling of the eyes, face, mouth, tongue or throat and difficulty breathing/swallowing
• Decreased urine output or edema (swelling of legs, ankles or feet)
• Changes in vision
• Dizziness and/or fainting
• Upper abdominal pain, fever, jaundice or clay-colored stool
• Rapid heartbeat

Risks of Semaglutide

Do not take semaglutide if you are pregnant or breastfeeding, or if you or anyone in your family has a history of medullary thyroid cancer (MTC), a rare type of thyroid cancer, or a history of multiple endocrine neoplasia type 2 (MEN 2), a rare endocrine condition, says Dr. Saunders. Let your doctor know if you have a history of pancreatitis or heavy alcohol consumption, as both can precipitate pancreatitis, she adds.

Additionally, if you’re taking semaglutide in addition to other medications to lower your blood glucose levels, your dose may need to be lowered when starting (or increasing) semaglutide to prevent hypoglycemia (very low glucose levels), says Dr. Saunders.

“Semaglutide, and all anti-obesity medications, are FDA-approved for long-term weight management because obesity is a chronic disease, just like hypertension and type 2 diabetes,” says Dr. Saunders. Individuals interested in semaglutide for obesity treatment should be comfortable with the idea of taking the medication long-term, she says.

A Word of Caution

“In response to growing demand for semaglutide and supply chain problems, some pharmacies are attempting to compound the medication,” says Dr. Saunders. Compounding medication is the process of combining, mixing or altering ingredients to create a tailored medication, per the FDA. Compounded medications for semaglutide have not been studied in rigorous randomized controlled trials, notes Dr. Saunders, and have not been approved for use by the FDA.

What’s more, compounded drugs are not regulated like FDA-approved medications, meaning their efficacy is unknown, and there are safety concerns, warns Dr. Saunders. “Due to the lack of regulatory oversight, it can be challenging to know what is contained in compounded drugs (similar to dietary supplements),” she says.

When to See a Doctor

Dr. Kanji advises asking your doctor these questions before taking semaglutide:

• Are there any reasons I can’t use semaglutide safely?
• Do I meet the criteria for using semaglutide for weight loss?
• Is this on-label or off-label use?
• What are the side effects of semaglutide?
• How long should I expect to use semaglutide?
• Will I gain weight back after stopping semaglutide?

And be sure to discuss the cost of semaglutide with your provider, says Dr. Saunders. “Insurance coverage for the medication is typically a major limitation for use, since the medication can be very expensive without coverage,” she says.

For individuals with obesity and multiple weight-related health complications who have lost and gained weight multiple times, the risk/benefit profile of semaglutide often makes sense, says Dr. Saunders.

Article Source: https://www.forbes.com/health/weight-loss/semaglutide/