Orforglipron
PMID 40960239 reports 7.5%, 8.4%, and 11.2% mean weight loss after 72 weeks across three orforglipron groups (checked: 2026-08-26). Placebo produced a 2.1% loss. The phase 3 trial randomized 3,127 adults. Eli Lilly funded the trial. The United States FDA approved Foundayo on April 1, 2026.
The UK MHRA authorized Foundayo on August 10, 2026 (checked: 2026-08-26).
Orforglipron is an oral small-molecule GLP-1 receptor agonist. It is not a peptide.
What is Orforglipron?
The drug activates the human GLP-1 receptor (United States FDA label; checked: 2026-08-26). Its approved U.S. product name is Foundayo.
Foundayo is a pill, not an injection.
The register lists the development code LY3502970.
| Identity field | Value | Source |
|---|---|---|
| Name | Orforglipron | GSRS |
| Development codes | LY-3502970; LY3502970 | GSRS |
| UNII | 7ZW40D021M | GSRS |
| CAS | 2212020-52-3 | GSRS |
The GSRS record supplies these fields (checked: 2026-08-26). A UNII is an identity code. It does not mean a drug is approved.
What did the ATTAIN-1 phase 3 trial report?
PMID 40960239 was a 72-week randomized, double-blind, placebo-controlled trial (checked: 2026-08-26). It enrolled adults with obesity and no diabetes. The trial record is NCT05869903. Eli Lilly funded the work.
All groups also received diet and physical-activity support. The main test was percentage change in body weight at week 72.
| Finding in PMID 40960239 | Result | Funding |
|---|---|---|
| People randomized | 3,127 | Eli Lilly |
| Mean weight loss across three active groups | 7.5%, 8.4%, and 11.2% | Eli Lilly |
| Mean weight loss with placebo | 2.1% | Eli Lilly |
| Lost at least 10% in the highest-result group | 54.6% | Eli Lilly |
| Lost at least 10% with placebo | 12.9% | Eli Lilly |
| Lost at least 15% in the highest-result group | 36.0% | Eli Lilly |
| Lost at least 15% with placebo | 5.9% | Eli Lilly |
| Lost at least 20% in the highest-result group | 18.4% | Eli Lilly |
| Lost at least 20% with placebo | 2.8% | Eli Lilly |
The 11.2% mean had a 95% confidence interval from 10.4% to 12.0% loss. The placebo mean had a 95% confidence interval from 1.4% to 2.8% loss.
Each active group beat placebo in the main test (p<0.001; PMID 40960239; checked: 2026-08-26).
These are group means. They do not mean that each person lost the same share.
What safety findings did ATTAIN-1 record?
Side effects led 5.3% to 10.3% of people in the active groups to stop treatment in PMID 40960239. The placebo result was 2.7%.
The most common events affected the stomach and gut. The paper graded most as mild or moderate. Eli Lilly funded the trial.
The trial lasted 72 weeks. It did not directly compare orforglipron with an injectable medicine.
What does the United States FDA label add from two trials?
The United States FDA label combines two weight trials with placebo (checked: 2026-08-26). It reports 3,155 people on the drug and 1,576 on placebo.
Eight percent of people on the drug stopped due to a side effect. The placebo result was 3%. Five percent stopped due to a stomach or gut effect.
| Common adverse reaction in the United States FDA label | Active groups | Placebo |
|---|---|---|
| Nausea | 26% to 35% | 10% |
| Constipation | 20% to 27% | 9% |
| Diarrhea | 21% to 25% | 11% |
| Vomiting | 13% to 24% | 4% |
| Indigestion | 12% to 16% | 4% |
| Abdominal pain | 13% to 14% | 7% |
| Headache | 8% to 9% | 7% |
| Abdominal distension | 7% to 9% | 3% |
| Fatigue | 6% to 9% | 4% |
| Burping | 6% to 8% | 1% |
| Gastroesophageal reflux disease | 6% to 7% | 2% |
| Gas | 5% to 6% | 2% |
| Hair loss | 4% to 5% | 2% |
Stomach and gut reactions occurred in 60% to 69% of the active groups. The placebo result was 37%. Among people on the drug who reported one, 4% called it severe.
| Other pooled finding in the United States FDA label | Active treatment | Placebo |
|---|---|---|
| Confirmed acute pancreatitis | 6 events in 6 people; 0.14 per 100 exposure-years | 2 events in 1 person; 0.04 per 100 exposure-years |
| Acute kidney injury | 0.2% | 0.05% |
| Hypotension | 2% | 0.5% |
| Gallstones | 1% | 0.7% |
| Acute gallbladder inflammation | 0.4% | 0.3% |
| Tachycardia-related events | 3% | 0.9% |
| Dizziness | 4% | 3% |
| Taste disturbance | 0.9% | 0.3% |
| Hypersensitivity reactions | 0.5% | 0.3% |
The active groups had a mean heart-rate rise of 4 to 5 beats per minute. Placebo had a rise of 0.5 beats.
The U.S. label has a boxed warning about thyroid C-cell tumors seen with some GLP-1 drugs in rodents. This drug was not active in rats or mice. It caused no tumors in those animals. The label says the link to people is not known.
Where is Foundayo approved?
| Jurisdiction | Current primary record | Status checked 2026-08-26 |
|---|---|---|
| United States | FDA approval | Approved April 1, 2026 for adult long-term weight management in the named population |
| United Kingdom | MHRA authorization | Authorized August 10, 2026 for weight management and type 2 diabetes |
| Central European Union register | EMA medicines register | No authorized Orforglipron row in the file generated August 26, 2026 at 06:00 |
The EMA page for EMEA-003299-PIP02-22 records a child-study plan. That plan is not a marketing authorization.
The MHRA said Foundayo was not yet available through the NHS on August 10, 2026. It said NHS use would follow the usual NICE process.
What are the evidence tier and EU status?
Evidence tier: A (checked: 2026-08-26). Foundayo has named U.S. and UK approvals. Phase 3 human data are published.
EU register status: investigational (checked: 2026-08-26). The current central register has no authorized row for the drug.
The UK is outside the European Union. Its approval does not change the central EU field.
The U.S. and UK records do not answer the EU question. Each place has its own record.
What does grey-market vial testing show?
The 2026 vial-study text lists fourteen compounds (checked: 2026-08-26). Orforglipron is not one of them.
The paper gives no Orforglipron identity, amount, purity, endotoxin, or sterility result. The absence applies to this paper, not every product in the market.
The study tested other drugs. It cannot give a result for a drug it did not test.
When was Orforglipron first observed outside research?
No sound first grey-market month is known (checked: 2026-08-26). The register keeps first_observed: null rather than estimating a date.
A date would be a guess. This page does not make one.
What does one user report?
The original day-one Orforglipron Reddit thread was opened on 2026-08-26. The account is self-reported, self-selected, and unpaid.
The author wrote:
The constant background thinking about food didn't vanish completely but it got dialed way down. I ate my normal lunch but I hit the "I'm done" wall way faster than usual and didn't even think about snacking until dinner. Quick breakdown of side effects so far: Headache: None. Nausea: Zero (surpisingly). Energy: Stable with no lethargy just a flat calm focus.
This is a one-day account. It does not establish how often the experience occurs. No laboratory verified the product described in the post.
One post is not a count. It is one person's story.