Higher doses of semaglutide can help lower blood sugar levels as well as help with weight loss, finds a new study published in The Lancet.
Currently, the highest approved dose of oral semaglutide that is prescribed is 14mg.
The study shows that the drug is useful and safe in even higher doses of 25 mg and 50 mg, one of the principal investigators of the study tells FIT.
The study is also the first one to include Indian subjects as a caveat.
FIT speaks to Dr KP Singh, director of endocrinology at Fortis Hospital Mohali and a researcher on this study.
Benefits and Side Effects: What the Study Found
Speaking to FIT about some of the key parameters of the study, Dr KP Singh says,
The study was conducted over a course of five years.
It was a multinational study conducted in nine countries across Asia, Europe, and North America, including India.
The study involved 709 participants of which 216 participants were from India.
Pregnant and breast-feeding women were kept out of the study.
The study participants were given one tablet once per day for 68 weeks, along with lifestyle intervention.
This is the first time that high doses of semaglutide (25 mg and 50 mg) were tested in clinical trials.
Before this, we have only used upto 14 mg, even in trials. And the drug in this dose showed 5 to 8 percent weight loss, along with blood sugar control in diabetes patients.
This study found that the drug in higher doses could aid up to 15 percent weight loss over a period of 68 weeks.
More than two-thirds of the study participants achieved at least 10 percent weight loss.
What about the side effects?
The study found that about 92 percent of the participants in the trial experienced adverse effects, as compared to 86 percent in the placebo group.
The adverse affects, according to the study authors, were mainly mild to moderate gastrointestinal issues, including diarrhoea and nausea.
Is Semaglutide Available in India?
Although injectable semaglutide (most popular kind being Ozempic) is not available in India, oral semaglutide has been available in India for over a year now. It is available in 3 mg, 7 mg, and 14 mg dosages.
However, they are only prescribed for specific cases of diabetes.
For one, semaglutide in India can only be prescribed by an endocrinologist, as per the Drugs Control General of India. Further, they can only be prescribed to treat uncontrolled Type-2 diabetes in adults.
Furthermore, oral semaglutide pills are not cheap in India, priced at Rs 300 a pill. Considering you need to take the pill daily, the bill could run up to Rs 10,000 a month.
People at the risk of pancreatitis and renal damage are not to be prescribed this drug, even if they meet the patient profile.
Semaglutides for Weight Loss
In India, the drug, either in injectable or oral form, is not approved for weight loss in people who don't have diabetes.
"Some people do take it off label, but we cannot prescribe them by law," says Dr Singh.
However, positive results in studies like this one make a strong case for its approval, he adds.
Since the whole frenzy around Ozempic and semaglutides for weight loss began online, its demand has gone up. But, experts are wary.
Apart from renal damage, semaglutide has also been linked to a possible increase in thyroid tumours, hypoglycemia, and allergic reactions.
According to experts, that FIT spoke to, because of these possible side effects, using it just for weight loss doesn't seem worth the risk.
Although, Dr Singh does say, "we didn't find hypoglycemia in our study participants."
Dr Singh believes that we're only scratching the surface when it comes to the potential benefits of semaglutide. However, they remain to be tested in clinical trials.
"We are also testing semaglutide in other ailments like cardiovascular issues, and non-alcoholic fatty liver disease (NAFLD). It's too early to say, but they are showing promise," says Dr Singh.
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