An appetite-suppressant pill being developed by scientists could help thousands lose weight safely with no obvious side effects, scientists say.
Experts have created a new protein that has safely reduced the weight of obese mice, rats and monkeys by up to 12 per cent in eight weeks.
The protein works by stimulating hormones that make you feel fuller and less hungry. It also boosts healthy gut bacteria that fight obesity by reducing the amount of fat absorbed by the body.
Developers hope to start testing the tablet in clinical human trials as early as next year.
Scientists say the protein, which is known as D3, although it has no relation to vitamin D3, can be turned into cheap tablets that could safely help thousands of obese people lose weight.
It is derived from human defensins proteins, or antibiotics, that protect against bacteria, funghi and viruses and can be produced in large quantities.
We are very excited about D3. Our research shows it has a great potential to be developed as an oral weight-loss drug, which will undoubtedly benefit society, said Professor Fangqing Zhao, of the Chinese Academy of Sciences in Beijing.
We are going to conduct clinical studies after some essential pre-clinical tests [on toxicity and finding a suitable material for the protein to bind with in the drug] perhaps with small-scale clinical results in one or two years.
The main advantage of D3 is that it can be taken orally, which can greatly improve the patient compliance. There are currently no appetite suppressants in a tablet form on the market. We hope to develop D3 as the safest and cheapest weight-loss drug.
D3 can not only suppress appetite, but also increase the abundance of the weight-loss bacteria Akkermansia muciniphila, a star bacterium that is thought to be strongly associated with lean body mass.
The study found the number of Akkermansia muciniphila increased about 100 times during the D3 treatment. It is unclear exactly how this bacteria helps a person lose weight.
However, a 2020 study in the journal Nutrition & Metabolism, that Professor Zhao was also involved in, concluded that it may play a decisive role in reducing the burden of obesity, via modulation of glucose metabolism and low-grade inflammation both of which are factors in obesity.
Experts in the field, who were not involved in the D3 project, welcomed the findings as extremely promising, while cautioning that the benefits have yet to be proved in humans.
This is an exciting novel study showing D3 acts to reduce obesity by stimulating the gut microbiome targeting healthy microbes like Akkermansia muciniphila, said Professor Tim Spector, of Kings College London, who runs the ZOE app, the worlds largest nutrition study and the worlds largest Covid study.
It may also work to reduce fat absorption and appetite. So far, it has only been shown to work in mice, rats and small monkeys but is a potentially very useful therapeutic if it also works in humans, as it doesnt need to be injected.
Professor Ted Dinan, an expert in the brain-gut-microbe axis at University College Cork, added: This is indeed an interesting series of studies. The weight reduction in the various animal models is impressive.
The fact that the gut microbiota is altered with increases in Akkermansia muciniphila strengthens the view that D3 has significant positive metabolic effects.
The weight-loss area is full of false positive findings in animals that fail to translate. The results are promising but require human replication.
If all goes well, however, Professor Dinan says D3 pills could be available for people to use in seven to 10 years.
The development puts its scientists at the forefront of fledgling field weight-loss pills and injections.
In the UK, just two anti-obesity medicine have been approved, neither of which is an appetite-suppressing pill.
They are orlistat, a weight loss pill that works by reducing fat absorption and liraglutide, an appetite-suppressing injection.
The US Food and Drugs Administration has approved three additional anti-obesity drugs but none of those are in tablet form while there are a handful of other promising trials of anti-obesity drugs that, as with D3, are at the animal-testing stage.
Among the drugs currently approved by the FDA for clinical use in the treatment of obesity, it seems that most of them have side effects. Common adverse reactions to these weight-loss drugs include gastrointestinal reactions, such as nausea and vomiting, Professor Zhao said.
Notably, no obvious side effects were observed in our study in mice, rats or macaques. But considering that our experiment was conducted only for 10 to 12 weeks, a longer experimentation period is needed for verification of the results, he added.
The study is published in the BMJ journal Gut microbiota.
Having demonstrated the safety and effectiveness of D3 in mice, rats and small monkeys, Professor Zhao and his fellow researchers are busy preparing a series of pre-clinical trials ahead of tests in people to see if it works as well in them.
These include tests to determine whether the new protein they have developed could be poisonous to humans and to work out what would constitute a safe, yet effective, dose.
The pre-clinical studies for drug registration require a long period of time, including druggability, pharmacological toxicology and pharmacokinetics, said Professor Zhao who is nonetheless hopeful of beginning small-scale human tests in the next year or two.
Druggability refers to finding the right molecules or drug material to successful bind to the D3 protein to produce a tablet that can hold together outside the body and break down inside it.
Pharmacokinetics, meanwhile, is concerned with the movement of drugs within the body.
If things go well, the scientists will conduct a series of human trials of various sizes in the next few years to demonstrate safety and effectiveness.
After that, they will seek approval from a regulatory probably the FDA in the US, which would typically be followed shortly after by the UK approval by the The Medicines and Healthcare products Regulatory Agency (MHRA).
If all continues to go well, a table could be available in seven to 10 years most likely on prescription for people with obesity.
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Hopes rise that world's first appetite-suppressant pill will help thousands lose weight safely - iNews
