An appetite suppressant drug being developed by scientists could help thousands of people lose weight safely without obvious side effects, scientists say.
Experts have created a new protein that safely reduces body weight in obese rats, rats and monkeys by up to 12% in 8 weeks.
Protein works by stimulating hormones that make you feel full and less hungry. It also reduces the amount of fat absorbed by the body, increasing healthy gut bacteria that fight obesity.
Developers hope to start testing tablets in clinical human trials as early as next year.
Scientists say it’s not related to vitamin D3, but a protein known as D3 could be turned into cheap tablets that could safely help thousands of obese people lose weight.
It is derived from human defenses (proteins or antibiotics) that protect against bacteria, fungi and viruses and can be produced in large quantities.
“We are very excited about the D3. “Our study shows that it has great potential to be developed as an oral weight loss drug,” said Zhao Fangqing, a professor at the Chinese Academy of Sciences.
“We’re going to go through a few essential preclinical tests before proceeding with a clinical study. [on toxicity and finding a suitable material for the protein to bind with in the drug] – Small clinical results will probably be available in one or two years.
“The main advantage of D3 is that it can be taken orally, which can significantly improve patient compliance. There are currently no appetite suppressants in tablet form on the market. We hope to develop D3 as the safest and most affordable weight loss drug.
“D3 can not only suppress appetite, but also increase the abundance of the weight-loss bacterium Akkermansia muciniphila.
Studies have shown that the number of Akkermansia muciniphila increased approximately 100-fold during D3 treatment. It’s unclear exactly how these bacteria help people lose weight.
However, a 2020 study in the journal Nutrition & Metabolism, involving Prof. Zhao, concluded that “it may play a crucial role in reducing the burden of obesity through regulation of glucose metabolism and low-grade inflammation.” become a factor in obesity.
Experts in the field, who were not involved in the D3 project, welcomed the findings as very promising, warning that they have not yet demonstrated any benefits for humans.
Professor Tim Specector of King’s College London, which runs the world’s largest nutritional research ZOE app, said, “This is an exciting new study in which D3 stimulates the gut microbiome to reduce obesity.
“It may also be effective in fat absorption and reducing appetite. So far, it has only been shown to be effective in rats, rats, and small monkeys, but since it does not require injections, it is a potentially very useful treatment if it works in humans as well.”
Professor Ted Dinan, an expert on the ‘brain-gut-microbe’ axis at University College Cork, added: “This is a really interesting series of studies. The weight loss in different animal models is impressive.”
“The fact that the gut microbiota is altered with increasing Akkermansia muciniphila reinforces the view that D3 has significant positive metabolic effects.”
“The weight loss area is full of false-positive results from animals that have failed to translate. The results are promising, but human cloning is needed.”
But if all goes well, D3 pills could be available to people in 7 to 10 years, says Professor Dinan.
This development puts scientists at the forefront of emerging field weight loss pills and injections.
In the UK, two anti-obesity drugs are approved, neither of which is an appetite suppressant.
They are orlistat, a weight loss pill that works by reducing fat absorption, and liraglutide, an appetite suppressant injection.
The U.S. Food and Drug Administration (FDA) has approved three additional obesity treatments, but none of them are in tablet form. On the other hand, as with D3, there are several promising trials for anti-obesity drugs that are in the animal testing stage. .
“Most of the drugs currently clinically approved by the FDA for the treatment of obesity seem to have side effects. Common side effects of these weight loss drugs include gastrointestinal reactions such as nausea and vomiting,” said Professor Zhao.
“No overt adverse effects were observed, particularly in our studies in mice, rats or monkeys. However, considering that the experiment was conducted for only 10 to 12 weeks, a longer experiment period is needed to verify the results.”
The study was published in the BMJ journal Gut microbiota.
What’s next?
After demonstrating the safety and effectiveness of D3 in rats, rats and small monkeys, Professor Zhao and colleagues are busy preparing a series of ‘preclinical’ trials to see if D3 works well in people.
This includes testing to determine whether a new protein they have developed could be toxic to humans and what constitutes a safe yet effective dose.
“Preclinical studies for drug registration take a long time, including pharmacological properties, pharmacological toxicology and pharmacokinetics.
Drug potential means finding a suitable molecule or drug substance to successfully bind to the D3 protein to create a tablet that can be held together outside the body and broken down inside.
On the other hand, pharmacokinetics relates to the movement of drugs within the body.
If all goes well, scientists will be conducting a series of human trials on different scales in the next few years to prove safety and effectiveness.
After that, they will seek regulatory approval. Probably the US FDA. UK approval from The Medicines and Healthcare products Regulatory Agency (MHRA) will usually follow.
If all goes well, the table will be available in 7-10 years. Perhaps a prescription for obese people.