Radically different
Nature Medicine, Published online: 13 May 2026; doi:10.1038/s41591-026-04386-7
As presented at the European Congress on Obesity, this randomized, placebo-controlled trial demonstrates that oral orforglipron, a nonpeptide GLP-1 receptor agonist, preserves weight loss and cardiometabolic benefits achieved with injectable GLP-1 receptor agonist therapies, making it a viable oral maintenance strategy.
Nature Medicine, Published online: 13 May 2026; doi:10.1038/s41591-026-04394-7
In a randomized trial, pasteurized Akkermansia muciniphila improved weight loss maintenance and metabolic health after a low-energy diet, especially in individuals with initially lower Akkermansia levels. The work suggests leveraging gut A. muciniphila as a potential target for weight management.
Nature Medicine, Published online: 13 May 2026; doi:10.1038/s41591-026-04397-4
This 2026 update integrates emerging trial evidence — particularly for weight loss and liver disease — to refine EASO’s treatment algorithm for obesity management.
Fractyl Health has received regulatory approval in the Netherlands to start the first-ever clinical trial for a gene therapy to treat type 2 diabetes. The upcoming Phase I/II clinical trial will test the safety and preliminary efficacy of RJVA-001, a gene therapy designed to locally deliver GLP-1 receptor agonist drugs with the goal of reducing the side effects associated with oral administration.
“GLP-1 medicines have changed what is possible in obesity and type 2 diabetes, but they require chronic, high-dose systemic exposure that many patients cannot or do not sustain,” said Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl Health. “RJVA-001 takes a different path: a potential one-time, pancreas-targeted gene therapy designed to enable the body to produce GLP-1 in response to meals: physiology, not pharmacology.”
Based in Burlington, Massachusetts, Fractyl Health develops novel approaches to treating obesity and type 2 diabetes. The company’s lead program, an endoscopic procedure to maintain weight loss after discontinuing GLP-1 treatment for obesity, is currently being evaluated in a pivotal clinical trial.
RJVA-001 leverages an engineered version of the human insulin promoter to trigger the production of GLP-1 in pancreatic beta cells when glucose levels rise after eating. The gene therapy is delivered using a minimally invasive endoscopic infusion directly into the pancreas, which is guided by ultrasound.
The Phase I/II study will evaluate the safety, tolerability, and preliminary efficacy of three escalating doses of the gene therapy. Participants will include adults with type 2 diabetes who have previously responded well to oral GLP-1 treatment yet continue to experience difficulties controlling their blood sugar levels.
“With this authorization, RJVA-001 becomes the first AAV gene therapy candidate to enter clinical development for type 2 diabetes,” said Rajagopalan. “We expect to dose the first patient and report initial data in the second half of 2026.”
Later this year, Fractyl expects to expand the study to additional sites in Australia, where the company has already submitted a clinical trial application and is currently awaiting a response from regulators.
RJVA-001 will be the first candidate from Fractyl’s Rejuva platform to enter clinical development. This smart GLP-1 gene therapy platform focuses on the development of next-generation adeno-associated virus (AAV)-based gene therapies that are locally delivered to the pancreas. Another candidate developed through this platform includes a dual GIP/GLP-1 gene therapy to treat obesity, currently in preclinical development.
“For decades, we have managed [type 2 diabetes] as a chronic, progressive disease that inevitably worsens over time. With this authorization, we are preparing to test, for the first time in humans, whether a one-time, pancreas-targeted gene therapy delivered via a routine endoscopic procedure could provide durable metabolic control by enabling physiologic, nutrient-responsive GLP-1 expression at the source of disease,” said Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy and deputy chair of the department of gastroenterology and hepatology at Amsterdam UMC, and a principal investigator of the upcoming clinical trial.
“Patients who remain inadequately controlled despite maximally tolerated GLP-1 receptor agonists and multiple oral agents represent a population with significant unmet need. If successful, RJVA-001 could transform how we think about [type 2 diabetes], from a chronic disease you manage every day to one that could potentially be treated once.”
The post First Clinical Trial for a GLP-1 Gene Therapy Greenlit in Europe appeared first on Inside Precision Medicine.
The European Union reached a provisional deal to strengthen the supply of essential medicines — such as antibiotics, insulin, vaccines, and painkillers — and avoid shortages by boosting domestic production and reducing reliance on imports.
Known as the Critical Medicines Act, the initiative seeks to avoid the kinds of withering drug shortages that were seen during the Covid-19 pandemic. Specifically, the proposal targets supply-chain weaknesses for more than 200 medicines that are considered critical to the region’s health security, including treatments for rare diseases.
“With today’s agreement, we are taking practical action to reduce our vulnerabilities, diversify supply chains and strengthen Europe’s capacity to produce critical medicines and their ingredients closer to home,” said Neophytos Charalambides, the health minister for Cyprus, in a statement.
Nature Medicine, Published online: 12 May 2026; doi:10.1038/s41591-026-04363-0
Announced in this Comment and in collaboration with Nature Medicine is the convening of the Data-Driven Decision Support in Obesity Management Commission, to promote adequate scientific evidence to support obesity management across global populations.
Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. Who could ask for anything more? Actually, we could. Specifically, we would like another cup of stimulation. So off we go to the Pharmalot cafeteria to fire up the coffee kettle. Our choice today is maple cinnamon French toast. Please feel free to join us. Meanwhile, we have assembled a few items of interest for you to peruse. We hope you have a smashing day and conquer the world. And of course, do stay in touch. …
The 17 pharmaceutical companies anchoring TrumpRx, the White House’s new prescription drug-pricing program, poured more than $130 million into federal lobbying in 2025 — a nearly 23% surge that outpaced the broader industry as the plan was being shaped behind the scenes, according to OpenSecrets, the nonprofit that tracks campaign financing and lobbying. Those companies accounted for more than a quarter of the record $457.3 million spent on lobbying last year across the pharmaceutical and health products industry. And while newly filed 2026 first-quarter reports show no slowdown — industry-wide spending topped $131 million, a 5.7% year-over-year increase — the most consequential lobbying push came in 2025, ahead of TrumpRx’s February launch.
Eli Lilly paused its obesity awareness campaign in India after the nation’s drugs regulator warned the company it could violate rules against advertising prescription medicines to consumers even indirectly, Reuters reports. The campaign titled “We Know Now” was launched in mid-2025, shortly after Lilly introduced its Mounjaro diabetes and obesity treatment in India. Its message focused on reframing obesity as a chronic disease rather than a personal failing. The campaign featured newspaper ads, social media posts, billboards, collaborations with Bollywood celebrities, and posters in a few residential communities. Lilly’s corporate logo appeared on the messages, but Mounjaro was not mentioned. In a 16-page letter dated April 10 and sent to the Drugs Controller General of India, Lilly said it had halted the campaign “out of an abundance of regulatory caution” following a March advisory from the regulator.