Orforglipron

Orforglipron (brand name Foundayo) is a prescription oral GLP-1 weight loss pill taken once daily at any time of day, with or without food, and without water restrictions. Orforglipron pill is FDA approved for chronic weight management in adults with obesity, or adults who are overweight and have weight-related medical problems.

Orforglipron should be used together with a reduced-calorie diet and increased physical activity to help reduce excess body weight and maintain weight loss long term.

Orforglipron is a small-molecule, non-peptide GLP-1 receptor agonist.

Eli Lilly's Foundayo (orforglipron) was approved by the FDA for weight management on April 1, 2026, it is not yet approved for other conditions.

Clinical trials investigating orforglipron for type 2 diabetes in those with obesity or overweight and increased cardiovascular risk, demonstrated that orforglipron decreased A1C, improved weight loss, and lower risk of major cardiovascular events (MACE-3).

Orforglipron for weight loss results (Trial 1)

Results from Trial 1 show that at week 72, patients taking orforglipron 17.2 mg lost an average of 11.1% of body weight (25.2 lbs), compared to 2.1% (4.8 lbs) with placebo. Patients taking orforglipron 9mg lost an average of 8.3% of their body weight (18.7 lbs), and patients taking 5.5mg lost 7.4% (16.8 lbs).

Orforglipron for weight loss results (Phase 3 ATTAIN-1 trial)

Results from Lilly’s Phase 3 ATTAIN-1 trial (NCT05869903) 72-week trial showed orforglipron helped people lose weight and keep it off.

Adults with obesity who took the highest investigational dose of orforglipron (36 mg capsules) lost an average of 27.3 pounds, or 12.4% of their body weight, compared with 2.2 pounds or 0.9% in the placebo group, in the efficacy analysis

The ATTAIN-1 trial also showed improvements in several cardiometabolic risk factors, including waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure

This trial used the orforglipron capsule formulation (1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg), which is the equivalent doses of once daily orforglipron tablets (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.

The maximum prescription orforglipron dose is 17.2 mg once daily.

Orforglipron is an oral GLP-1 receptor agonist that helps with weight loss by mimicking GLP-1, a natural hormone released after eating. GLP-1 helps regulate appetite, food intake, and digestion. Foundayo works by reducing hunger, increasing feelings of fullness, and slowing stomach emptying, which can help people eat less and feel satisfied longer.

Unlike some other oral GLP-1 medications, Orforglipron is a small-molecule, non-peptide GLP-1 receptor agonist. This makes it much more effectively absorbed in the pill form compared to other oral GLP-1 medications.

Orforglipron can be taken once daily at any time of day without food or water restrictions. This may make it more convenient than oral semaglutide, which must be taken on an empty stomach with a small amount of water and requires a waiting period before food, drink, or other medicines.

Orforglipron for diabetes showed significant improvements in blood sugar control and body weight in the Phase 3 ACHIEVE-4 trial. The study compared orforglipron with insulin glargine in adults with type 2 diabetes, obesity or overweight, and increased cardiovascular risk over 52 weeks.

ACHIEVE-4 trial results showed that orforglipron reduced A1C by 1.6%, compared with 1.0% for insulin glargine. It also led to 8.8% weight loss, while the insulin glargine group gained 1.7% body weight. For time to first major adverse cardiovascular events (MACE-3), the hazard ratio was 0.77, indicating a numerically favorable trend, but the finding was not statistically significant (p = 0.181).

• Take orforglipron exactly as prescribed.
• Use it together with a reduced-calorie diet and increased physical activity.
• Take a orforglipron pill by mouth once daily, with or without food.
• Swallow tablets whole. Do not break, crush, or chew them.
• Your dose is increased gradually over time to help your body adjust to the medicine and improve tolerability.
• If you miss a dose, take it as soon as possible. Do not take 2 doses in the same day.
• Do not take more than 1 tablet per day.
• If you miss treatment for 7 or more days in a row, contact your healthcare provider before restarting.
• If you take too much, call your healthcare provider, Poison Help (1-800-222-1222), or go to the nearest emergency room.

The Foundayo dosing schedule begins with 0.8 mg once daily and increases gradually over time. Dose escalation typically occurs after at least 30 days at each step, depending on how well the medication is working and how well it is tolerated.

The dosing steps are:

• 0.8 mg once daily at the start
• 2.5 mg once daily after at least 30 days
• 5.5 mg once daily after at least 30 days
• 9 mg once daily after at least 30 days, if needed
• 14.5 mg once daily after at least 30 days, if needed
• 17.2 mg once daily after at least 30 days, if needed

The Foundayo dose is increased step-by-step to minimize side effects while helping patients reach an effective maintenance dose. Because dose increases depend on individual response, some patients may remain on a lower dose longer, while others may continue to increase as directed by their healthcare provider.

The maximum prescription dosage is 17.2 mg once daily.

Foundayo is supplied as oral tablets in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg strengths.

Orforglipron has a boxed warning for the increased risk of thyroid C-Cell tumors. A boxed warning is the strongest safety-related warning issued by the FDA.

• Possible thyroid tumors, including thyroid cancer. Tell your healthcare provider right away if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In rodent studies, medicines like these caused thyroid tumors, including thyroid cancer. It is not known whether this medicine causes thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
• Do not take this medicine if you or anyone in your family has ever had medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not take this medicine if:

• you have a personal or family history of MTC or in patients with MEN 2
• Known serious hypersensitivity to the active ingredient orforglipron or any of the inactive ingredients found in the medicine.

Common side effects

The most common orforglipron side effects are nausea, stomach (abdominal) pain, heartburn, constipation, headache, gas, diarrhea, bloating, hair loss, vomiting, tiredness, indigestion, and belching.

Serious side effects

Also, see “Boxed Warnings?”

This medicine may cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis). Stop taking this medicine and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use orforglipron. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use orforglipron with medicines that can cause low blood sugar, such as insulin or sulfonylurea. Signs and symptoms of low blood sugar may include:
• Serious allergic reactions. Stop taking this medicine and get medical help right away if you have any symptoms of a serious allergic reaction, including:
• Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with this medicine.
• Gallbladder problems. Gallbladder problems have happened in some people who use this medicine. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
• Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). orforglipron may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking this medicine before you are scheduled to have surgery or other procedures.

Talk to your healthcare provider if you have any side effects that bother you or that do not go away. These are not all the possible side effects of orforglipron. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

When comparing orforglipron to existing oral GLP-1 therapies like Wegovy (semaglutide), the primary distinction lies in their molecular structure and administration requirements.

Why Foundayo Offers More Flexibility

Unlike traditional GLP-1 agonists, orforglipron is a small-molecule, nonpeptide medication. This structural advantage leads to several patient benefits:

• Enhanced Bioavailability: Its small-molecule design allows the body to absorb the medication more efficiently through the digestive tract.
• No Fasting Required: You can take orforglipron at any time of day, regardless of food or liquid intake.

The Challenges of Peptide-Based Medications

In contrast, oral Wegovy (semaglutide) is a peptide-based molecule. Because peptides are large and fragile, they are easily broken down by stomach acid before they can reach the bloodstream. To combat this, oral semaglutide requires:

• Strict Dosing Schedules: It must be taken on an empty stomach with no more than 4 ounces of plain water.
• Wait Times: Patients must wait at least 30 minutes before eating or drinking anything else.
• Chemical Enhancers: It relies on salcaprozate sodium (SNAC), an absorption enhancer, to protect the peptide and facilitate its passage into the blood.

• Tell your healthcare provider about all medical conditions and all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
• Tell your provider if you have or have had pancreas problems, kidney problems, severe liver problems, severe stomach problems such as gastroparesis, or a history of diabetic retinopathy.
• Tell your provider if you are scheduled for surgery or another procedure using anesthesia or deep sedation.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Orforglipron may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking this medicine.

• Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about your health and that of your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
• Birth control pills by mouth may not work as well while taking this medicine. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 30 days after you start orforglipron and for 30 days after each increase in your dose of orforglipron. Talk to your healthcare provider about birth control methods that may be right for you while using this medicine.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with orforglipron. Talk to your healthcare provider about the best way to feed your baby while using this medicine.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from light by keeping the tablets in the original bottle and carton and replacing the cap after opening.
• If the carton is no longer available, keep the bottle away from light.
• Keep out of the reach of children.

Foundayo will be available through LillyDirect, with prices starting at $25 per month for eligible commercially insured patients, and self-pay pricing starting at $149 per month for the lowest dose. Lilly also said some eligible Medicare Part D beneficiaries may be able to access Foundayo for $50 per month beginning as soon as July 1, 2026.

Availability and pricing programs can change. Coverage, eligibility rules, and retail pharmacy access should be verified before prescribing or dispensing.

Store between 68°F to 77°F (20°C to 25°C).

Foundayo tablets are sensitive to light. Protect tablets from light by keeping it in the original bottle and carton and replacing the cap each time after opening.

If you no longer have the carton, store the bottle away from light.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Active ingredient: orforglipron

Inactive ingredients: Copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous.

The film coating contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of the 0.8 mg and 9 mg tablets also contains ferric oxide red and ferric oxide yellow. The 2.5 mg. and 14.5 mg tablets also contain ferric oxide yellow, and 5.5 mg and 17.2 mg tablets also contain ferrosoferric oxide and ferric oxide red.