Today : Dec 22, 2025
Health
22 December 2025

Eli Lilly Seeks FDA Approval For Weight Loss Pill

The new oral drug orforglipron shows promise for sustaining weight loss after stopping injectables, but patient experiences reveal challenges in keeping the weight off.

For millions grappling with obesity or Type 2 diabetes, the advent of GLP-1 medications has been nothing short of a revolution. These drugs, which mimic a hormone that regulates hunger, have enabled many to shed pounds and, perhaps more importantly, to quiet the relentless "food noise" that so often sabotages weight loss efforts. But as these medications become more common, a pressing question has emerged: what happens when you stop taking them?

This December, Eli Lilly announced it had asked the Food and Drug Administration for approval of orforglipron, a new oral GLP-1 medication. According to Eli Lilly, orforglipron could offer a more convenient alternative to the current injectable GLP-1 drugs like Wegovy, Zepbound, and Mounjaro, which have transformed the weight loss landscape but come with their own challenges and uncertainties.

The company’s request follows a series of promising Phase 3 trials. In one, participants who had previously used injectable drugs such as Wegovy lost an average of 41 pounds. After switching to orforglipron for a year, they regained just two pounds. Those who had used Zepbound lost an average of 55 pounds, and after a year on orforglipron, regained 11 pounds. Importantly, those taking orforglipron kept off more weight than participants who received a placebo, even though both groups received similar diet and exercise counseling.

“Obesity is a chronic, progressive disease, and sustaining weight loss remains a significant challenge for many,” said Kenneth Custer, Eli Lilly’s executive vice president and president of Lilly Cardiometabolic Health. He emphasized that orforglipron “helped people maintain the weight they worked hard to lose” and allowed patients “to switch directly from the highest tolerated doses of available injectable therapies onto oral doses of orforglipron.”

Orforglipron’s promise extends beyond weight maintenance. In another Phase 3 study involving people with Type 2 diabetes, those taking the highest dose of orforglipron lost an average of 10.5% of their body weight after 72 weeks. Participants on lower doses lost between 5.5% and 7.8%. All study participants were considered overweight or obese, underscoring the drug’s potential for a population at high risk of weight-related complications.

But the excitement around these medications is tempered by growing concerns over what happens when patients stop taking them. As reported by BBC News on December 21, 2025, the experiences of people coming off GLP-1 injections are often fraught with difficulty. Tanya Hall, a sales manager at a fitness company, lost six stone (about 38 kilograms) using Wegovy. Yet, each time she tried to stop the injections, she described an overwhelming return of hunger: “It’s like a switch that goes on and you’re instantly starving.” After stopping, she found herself eating so much that she was “completely horrified.”

Hall’s journey began as a personal experiment—she wanted to see if being slimmer would change how she was perceived in her industry. The results were stark: not only did she lose significant weight, but she also noticed a shift in how others treated her. “After I started using the jabs, people would come up to me and congratulate me on my weight loss. I felt I was treated with more respect,” she told BBC News. However, the side effects were not trivial. Hall struggled with sleep, persistent nausea, headaches, and even hair loss, which she suspects was linked to rapid weight loss. Despite these challenges, she found the benefits—both physical and social—hard to relinquish.

The struggle to maintain weight loss after stopping GLP-1 drugs is not unique to Hall. Ellen Ogley, another patient profiled by BBC News, began using Mounjaro after a health scare forced her to confront her weight. “I was an emotional binge eater,” Ogley recalled. The medication helped her lose over eight stone (51 kilograms) and, for the first time, she found herself able to make healthier choices and exercise more. But after tapering off the drug over six weeks, her weight began to creep back up. “It messed my head up a little bit,” she admitted.

These personal stories are echoed by medical experts. Dr. Hussain Al-Zubaidi, a UK-based lifestyle GP, likened the experience of stopping GLP-1 drugs to “jumping off a cliff.” He explained, “I often see patients who will come off it when they’re on the highest dose because they’ve reached their target and then they stop.” The result can be an “avalanche or a tsunami” of hunger, with evidence suggesting that 60 to 80% of lost weight can return within one to three years of stopping the medication.

The UK’s National Institute for Health and Care Excellence (NICE) has recognized the need for ongoing support. It recommends at least a year of tailored advice and action plans after patients stop taking weight-loss drugs. The goal is to help individuals make lasting lifestyle changes to keep the weight off and stay healthy. However, for the many patients who pay for these medications privately, such support is not always available.

For some, the fear of regaining weight is so great that they choose to stay on the medication indefinitely, despite side effects and uncertainties about long-term use. Hall admits, “There’s part of me that feels like there’s an addiction to keep it going because it makes me feel the way that I feel, it makes me feel in control.” Yet she also wonders if, in reality, “it’s the drug that controls her.”

Ogley, on the other hand, has decided to close that chapter. She wants others to know that “life after Mounjaro can be sustainable as well.” But as Dr. Al-Zubaidi cautions, “Obesity is not a GLP-1 deficiency.” Without broader changes to the environments people live in—changes that promote health rather than weight gain—many will find themselves caught in a cycle of weight loss and regain.

Eli Lilly, the maker of both Mounjaro and the new orforglipron, maintains that “patient safety is Lilly’s top priority” and that it “actively engages” in monitoring and reporting information to regulators and prescribers. As orforglipron moves closer to potential FDA approval, it may offer a new tool for those seeking to maintain weight loss after injectables. Yet, the stories of Hall, Ogley, and countless others highlight that medication alone is rarely a complete solution. The journey to lasting weight loss, it seems, is as much about support, mindset, and environment as it is about the latest pharmaceutical breakthrough.

As the medical community awaits the FDA’s decision on orforglipron, patients and providers alike are left weighing the promise of new treatments against the hard realities of what happens when the drugs stop.