If you have ever followed GLP-1 news, you have probably noticed the same pattern that shows up again and again. Many people can lose weight on these medications, but keeping that weight off can be the harder part.
That is the problem Eli Lilly is trying to solve with its once daily oral GLP-1 pill, orforglipron.
On December 18, 2025, Lilly said new Phase 3 results show orforglipron helped people maintain most of the weight they had already lost after using injectable GLP-1 medications. Lilly also said it has now submitted the drug to the U.S. Food and Drug Administration (FDA) for approval. [1]
Here's what happened, what the study actually tested, and why this matters in the bigger GLP-1 timeline.
Quick takeaways
- Lilly says its oral GLP-1 drug orforglipron helped people maintain weight loss after injectable GLP-1 therapy in a Phase 3 trial. [1]
- The study focused on “maintenance,” meaning keeping weight steady after prior weight loss, not starting from scratch.
- Lilly says it has submitted orforglipron to the FDA, and the review could move faster because of the FDA’s Commissioner’s National Priority Voucher program. [2]
What Lilly announced
Eli Lilly announced it has submitted orforglipron, an oral GLP-1 drug, to the FDA after reporting positive Phase 3 maintenance data. [1]
A GLP-1 is a type of medication that affects appetite and blood sugar pathways. Many people know GLP-1s because of well known injectable drugs used for weight management and diabetes care.
Orforglipron is different in a simple way. It is a pill taken daily, not a weekly injection.
Lilly also noted that orforglipron has been tied to the FDA’s Commissioner’s National Priority Voucher pilot program, which is designed to shorten FDA review timelines for selected applications. [2]
What the ATTAIN-MAINTAIN trial studied
The ATTAIN-MAINTAIN trial looked at whether people could maintain their earlier weight loss after switching from injectable GLP-1 drugs to oral orforglipron.
Here is the basic setup.
Participants had already been on injectable GLP-1 therapy for a long period. Lilly said ATTAIN-MAINTAIN enrolled 376 people who previously received tirzepatide (Zepbound) or semaglutide (Wegovy) in another study. [1]
Then, after that earlier phase, participants were switched to either orforglipron or placebo.
Placebo is a pill with no active drug. It is used in studies so researchers can compare outcomes against a group that is not taking the medicine being tested.
The point of this trial was not “how much weight can someone lose.” It was “can people keep most of it off after they have already lost it.”
What the results showed
Lilly reported that people who switched to orforglipron maintained more of their prior weight loss over 52 weeks than people who received placebo. [1]
Lilly’s top line results also included a detail many readers will focus on.
- People who switched from Wegovy to orforglipron had weight change that was close to flat, within about 1 kg, on average. [3]
- People who switched from Zepbound to orforglipron regained more, about 5 kg on average, based on Lilly’s summary.
Different outlets have described these numbers slightly differently depending on which comparison point they highlight. Lilly’s own release includes additional context, including analyses at earlier time points and comparisons versus placebo. [1]
The clean takeaway is still the same.
This trial supports the idea that an oral option could play a role in the “after” phase, when people are trying to hold onto progress.
Safety and tolerability observations
Lilly said the most common side effects seen with orforglipron were gastrointestinal and generally mild to moderate, which is consistent with what has been reported in other GLP-1 studies. [1]
Lilly also reported discontinuation rates due to adverse events in the single digit percentages across groups, and said no hepatic safety signal was observed in this dataset.
This is early, top line reporting. More detailed trial data is expected to be presented at a future medical meeting, according to Lilly.
Why maintenance matters in GLP-1 treatment
Weight maintenance has become a major focus in GLP-1 care because many people struggle to stay on treatment long term.
Some people stop because of side effects. Some stop because of cost. Some stop because the process is hard to keep up with week after week. Some stop because they hit a plateau and feel stuck.
That is why maintenance matters as a strategy, even beyond any single drug.
A daily pill will not automatically solve adherence, but it can change the friction for some people. The fact is this: It may feel simpler than injections. For others, it may not.
What this news signals is that GLP-1 companies are not only competing on weight loss. They are also competing on what happens after the initial results.
What happens next
The next step is the FDA review of Lilly’s application.
The reason people are watching the timeline closely is the FDA’s Commissioner’s National Priority Voucher pilot program. The FDA says this program is meant to reduce review time from the typical 10 to 12 months to about 1 to 2 months for selected submissions, while keeping the standard review rigor. [2]
That does not mean automatic approval. It means the process can move faster.
Lilly is not the only company pushing oral options. Competing oral GLP-1 programs are also in development, including oral semaglutide efforts from Novo Nordisk. [4]
For now, the most accurate statement is simple.
Lilly has reported Phase 3 maintenance results, and the company says it has now filed for FDA approval. [1]
This is a developing story, stay tuned for more!
Sources
- [1] Eli Lilly press release: https://investor.lilly.com/news-releases/news-release-details/lillys-orforglipron-helped-people-maintain-weight-loss-after
- [2] FDA overview: Commissioner’s National Priority Voucher (CNPV) Pilot Program: https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
- [3] Reuters coverage summarizing reported weight change figures: https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-pill-maintains-weight-loss-after-switching-injectables-trial-2025-12-18/
- [4] Novo Nordisk release on oral semaglutide 25 mg and regulatory status context: https://www.prnewswire.com/news-releases/novo-nordisk-presents-four-new-analyses-on-oral-semaglutide-25-mg-wegovy-in-a-pill-at-obesityweek-2025-including-demonstrated-reductions-in-cardiovascular-risk-factors-302605329.html
