A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once- Daily Oral Orforglipron Compared With Placebo in Chinese Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

The purpose of this study is to learn how well orforglipron works and how safe it is in Chinese adults with obesity or overweight and related health problems. Participation in this study will last about 53 weeks (about 1 year).

Start Date01 Dec 2026

Sponsor / Collaborator

Eli Lilly & Co.

NCT07729332

/ Not yet recruitingPhase 4IIT

Switching to Oral Weight Management Pharmacotherapy to Prevent Weight Regain After GLP-1-based Therapy Discontinuation

This study will compare the effect of orforglipron and phentermine on weight maintenance.

Start Date01 Nov 2026

Sponsor / Collaborator

The Massachusetts General Hospital

NCT07739537

/ Not yet recruitingPhase 4IIT

Polygenic Assessment and Testing of Heterogeneity and Subtypes in Type 2 Diabetes (PATHS-T2D): A Recall-by-Genotype Study of Physiologic and Pharmacologic Responses

This research study aims to learn about how the body responds to food through different genetic pathways and how these responses may change during a short course of orforglipron. Orforglipron is an oral glucagon-like peptide-1 (GLP-1) receptor agonist that was approved by the U.S. Food and Drug Administration (FDA) on April 1, 2026, for long-term weight management. In longer studies, it has helped people lose weight and improve blood sugar, blood pressure, and cholesterol. By taking part, participants will receive detailed metabolic testing and may receive study results with additional information about their blood sugar and metabolic health.

Start Date01 Oct 2026

Sponsor / Collaborator

The Massachusetts General Hospital

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Oct 2026·Lancet Diabetes & Endocrinology

Safety and tolerability of orforglipron in Japanese people with type 2 diabetes

Article

Author: Nauck, Michael A ; Horowitz, Michael

01 Oct 2026·Lancet Diabetes & Endocrinology

Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial

Article

Author: Takeuchi, Masakazu ; Yabe, Daisuke ; Suzuki, Ryo ; Ugai, Hiroyuki ; Shiraiwa, Toshihiko

BACKGROUND:

Orforglipron, an oral GLP-1 receptor agonist, requires further evaluation in east Asian populations with type 2 diabetes, given this group's distinct pathophysiological characteristics. This study aimed to assess orforglipron as add-on treatment to diet and exercise alone or to oral antihyperglycaemic medications in Japanese participants with type 2 diabetes.

METHODS:

This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan. Adults with type 2 diabetes and elevated glucose levels managing their condition with diet and exercise alone or with one or two oral antihyperglycaemic medications were assigned (1:1:1) via computer-generated random sequence to receive once-daily oral orforglipron (3 mg, 12 mg, or 36 mg). Randomisation was stratified by background therapy, baseline HbA_1c (≤8·5% or >8·5%), and metformin use (yes vs no; applied only to α-glucosidase inhibitors, thiazolidinedione, and glinides). Investigators, participants, and site staff were not masked to treatment. The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron. This study is registered with ClinicalTrials.gov, NCT06010004 (ACHIEVE-J).

FINDINGS:

Between Sept 28, 2023, and June 5, 2025, 450 participants were screened and 401 were randomly assigned to three groups (3 mg, n=132; 12 mg, n=135; and 36 mg, n=134). 352 (88%) completed study treatment. 339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups. Most TEAEs were of mild (267 [67%, 61·8-71·0]) or moderate (63 [16%, 12·5-19·6]) severity. Discontinuations due to an adverse event occurred in 19 of 134 participants (14%, 95% CI 9·3-21·1) in the 36-mg group compared with seven of 132 (5%, 2·6-10·5) in the 3-mg group and 11 of 135 (8%, 4·6-14·0) in the 12-mg group. Across treatment groups, gastrointestinal symptoms were the most common TEAEs leading to study treatment discontinuation (3 mg: 5 [3·8%, 1·6-8·6]; 12 mg: 8 [5·9%, 3·0-11·3]; and 36 mg: 11 [8·2%, 4·7-14·1]). Level 2 (blood glucose <54 mg/dL) hypoglycaemia events occurred in three of 135 participants in the 12-mg group (2%, 0·8-6·3) and in three of 134 in the 36-mg group (2%, 0·8-6·4) groups. No level 3 (severe) hypoglycaemia events occurred. Outcomes were generally similar across background therapies.

INTERPRETATION:

Treatment with orforglipron in combination with diet and exercise alone or one or two oral antihyperglycaemic medications for 52 weeks demonstrated an acceptable safety profile in Japanese adults with type 2 diabetes.

FUNDING:

Eli Lilly.

TRANSLATION:

For the Japanese translation of the abstract see Supplementary Materials section.

01 Oct 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical Characterization of Enzyme and Transporter Precipitants to Evaluate Drug–Drug Interactions for Orforglipron, a Small Molecule Glucagon‐Like Peptide‐1 Receptor Agonist

Article

Author: Aithal, Keerthan ; Nicoll, Clare ; Morse, Bridget L. ; Raha, Sohini ; Coutant, David E. ; Bhattachar, Shobha ; Ma, Xiaosu ; Rougée, Luc R. A.

Orforglipron is an orally administered, small‐molecule glucagon‐like peptide‐1 receptor agonist in clinical development for the treatment of type 2 diabetes and obesity. Orforglipron is a substrate of CYP3A4, organic anion transporting polypeptides (OATPs) 1B/1B3, and P‐glycoprotein (P‐gp); however, precipitants commonly used to define these mechanisms have not been fully characterized. The enzyme‐ and transporter‐mediated DDI profile of orforglipron and that of CYP3A4/OATP1B/P‐gp precipitants were characterized in six phase 1 clinical studies in healthy participants. Orforglipron pharmacokinetics were assessed with clarithromycin, carbamazepine, cyclosporine, and quinidine. Precipitant effects on CYP3A and OATP1B activity were measured using midazolam and coproporphyrin‐I (CP‐I). Orforglipron effects on CYP3A, P‐gp, BCRP, and OATP1B were evaluated using midazolam, digoxin, rosuvastatin, simvastatin, atorvastatin, and CP‐I. Mechanistic interrogation of the simvastatin interaction was also conducted. Clarithromycin, carbamazepine, and quinidine had minimal effect on CP‐I pharmacokinetics, while the cyclosporine effect was substantial. Cyclosporine and quinidine weakly increased midazolam exposure. Orforglipron exposure increased in the presence of clarithromycin and cyclosporine and decreased with carbamazepine, demonstrating orforglipron exposure is affected by precipitants of CYP3A4 and OATP1B. Quinidine did not meaningfully change orforglipron exposure. Orforglipron had no clinically meaningful effect on the exposure of midazolam, digoxin, or atorvastatin. A weak increase in rosuvastatin exposure was consistent with BCRP inhibition, as CP‐I data confirmed orforglipron does not affect OATP1B. Increase in simvastatin acid exposure was attributed to the unique disposition of simvastatin rather than enzyme or transporter inhibition. These findings address mechanistic precipitant knowledge gaps and provide a framework for managing potential orforglipron DDIs in clinical practice.

419

News (Medical) associated with Orforglipron

7 hours ago

·www.prnewswire.com

Lilly launches the Lilly Change the Course Commitment, aiming to address treatment gaps in diabetes and obesity in LMICs

Through this commitment, Lilly aims to expand access to its innovative diabetes and obesity medicines to as many people in resource-limited settings, including low- and middle-income countries (LMICs), as in high-income countries, before 2040 Key highlights: Lilly today launched the Lilly Change the Course Commitment, a new global health initiative with a simple, yet ambitious goal: parity in the number of patients treated. This means treating as many people in resource-limited settings, including LMICs1, as in high-income countries. As a medicine company and a leader in diabetes care for over a century, Lilly is stepping up to help close a long-standing access gap in prevention, detection, treatment and care of diabetes and obesity. As part of the commitment, Lilly will register its innovative diabetes and obesity medicines in LMICs and work with health systems, regulators, global health organizations, NGOs and other collaborators to help more people in resource-limited settings access the medicines and care they need. The commitment follows the completion of the Lilly 30x30 global health initiative, which helped expand access to quality healthcare for 40 million people in resource-limited settings in 2025, surpassing its original goal of helping 30 million people annually by 2030 — five years ahead of schedule. INDIANAPOLIS, Sept. 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) is launching today the Lilly Change the Course Commitment, a new global health initiative that aims to achieve parity in patients treated with Lilly's innovative diabetes and obesity medicines. This means treating as many people with diabetes and obesity in resource-limited settings, including low- and middle-income countries (LMICs), as in high-income countries before 2040. Today, for every 4 people in high-income countries who have access to Lilly's diabetes and obesity medicines, only 1 person in low- and middle-income countries can reach them. To close this gap, Lilly will focus on three pillars: starting from clinical development of medicines, their registration and access pathways and health systems strengthening. The announcement follows the completion of the Lilly 30x30 global health initiative five years ahead of schedule, which expanded access to quality healthcare for 40 million people in resource-limited settings in 2025 – exceeding its original goal of reaching 30 million people annually by 2030. Why is Lilly launching a new commitment now? 4 in 5 adults with diabetes and 7 in 10 adults with obesity live in LMICs, 2-4 and prevalence continues to rise. Historically, people in resource-limited settings have waited decades to access innovative medicines, long after their availability in high-income countries. As a result, the therapies capable of changing the trajectory of diabetes and obesity are still not reaching the people who need them. For more than a century, Lilly has been developing innovative medicines for people living with diabetes and obesity. As a leader in this field, Lilly aims to ensure that access to medicines keeps pace with scientific innovation. David A. Ricks, Lilly chair and CEO: "For 150 years, Lilly has addressed some of humanity's most pressing health challenges by turning science into medicines that improve lives. That same commitment to scientific progress has transformed how we understand and treat diabetes and obesity, conditions that affect more than a billion people worldwide. But innovation only matters when it reaches the people who need it. That is why, as a medicine company that puts health above all, we are now going further. With the Lilly Change the Course Commitment, we aim to treat as many people in resource-limited settings as we do in high-income countries with our diabetes and obesity medicines. Innovative medicines like Foundayo (orforglipron), an oral treatment that can be stored at room temperature, will help us distribute and scale access across more LMICs." How will Lilly close the gap? Barriers in resource-limited settings extend beyond the availability of treatment and include fragmented health systems, limited healthcare infrastructure and persistent access gaps. To address them, the Lilly Change the Course Commitment is organized around three focus areas: Developing medicines for people who need them: Lilly is working to ensure its diabetes and obesity medicines are suitable for people living in resource-limited settings from the earliest stages of clinical development, focusing on clinical trials, medical presentations and cold chain storage. Registering and expanding access to medicines to reach people sooner: Lilly intends to register its innovative diabetes and obesity medicines, including GLP-1s, in more low- and middle- income countries, working with regulatory agencies and local health systems to expand access sooner, with a focus on Africa, Latin America and Asia. Helping strengthen health systems: Lilly aims to collaborate with global health organizations to help strengthen primary health systems by training community health workers, leveraging technology and digital tools, and improving disease awareness, prevention, diagnosis, and care in resource-limited settings. Together, these efforts aim to help more people extend their lifespan and enhance their quality of life by managing their diabetes and obesity earlier, reducing long-term complications, and, over time, preventing new cases of diabetes and obesity. How will Lilly measure and report progress? Lilly will report progress in treatment reach against the Lilly Change the Course Commitment through its annual Sustainability Report and at key global health forums. About Foundayo™ (orforglipron) Foundayo™ (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day with no planning around food or drink.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orfoglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. INDICATION AND SAFETY SUMMARY WITH WARNINGS Foundayo™ (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings — Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo 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 Foundayo. 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 Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. 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 the health of you and 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). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider: Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? Do you have a history of diabetic retinopathy? Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby. Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com . This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 Foundayo™ is a trademark of Eli Lilly and Company. Endnotes Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. . Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.  About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. I-LLY Trademarks and trade names Trademarks and trade names in this release are the property of Lilly or their respective owners. The ® and ™ symbols are omitted for convenience only and do not waive any party's rights. Use of other companies' marks does not imply their endorsement, sponsorship, or affiliation. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the Lilly Change the Course Commitment and reflects Lilly's current beliefs and expectations. However, there can be no assurance that the Lilly Change the Course Commitment will achieve Lilly's objectives or that Lilly will execute its strategy as planned. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Endnotes and references 1. Low- and middle-income countries (LMICs) are defined by the World Bank based on gross national income (GNI) per capita. For the current fiscal year, low-income economies are those with 2025 GNI per capita of $1,175 or less; lower-middle-income, $1,176–$4,635; upper-middle-income, $4,636–$14,375; high-income, above $14,375. World Bank Country and Lending Groups. Accessed Sept. 2026. 2. International Diabetes Federation. Global Diabetes Report 2000–2050. IDF Diabetes Atlas. Accessed Sept. 1, 2026. 3. Ahmed SK, Mohammed RA. Obesity: prevalence, causes, consequences, management, preventive strategies and future research directions. Metabol Open. 2025;27:100375. doi:10.1016/j.metop.2025.100375 4. Phelps NH, Singleton RK, Zhou B, et al. Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. The Lancet. 2024;403(10431):1027-1050. doi:10.1016/S0140-6736(23)02750-2 Refer to: Karine Mendelek; [email protected] (Media) Michael Czapar; [email protected] (Investors) SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Drug Approval

22 Sep 2026

·firstwordpharma.com

Details of Trump's drug pricing deals reveal GLP-1 exemptions, revenue sharing

Although US President Donald Trump has touted the 27 most-favoured nation (MFN) deals his administration has signed with large pharmas and mid-sized drugmakers as an unprecedented move to lower drug prices, the lack of specifics has made their effect on Americans' medication spending hard to judge. Now, thanks to Public Citizen's lawsuit over its unanswered Freedom of Information Act requests, some — heavily redacted — details on the deals Eli Lilly and Pfizer inked with the US Department of Health and Human Services (HHS) have been made public — and the organisation is highly sceptical that patients will reap the benefits of drug pricing agreements. "The Trump team may be doing more to protect pharma profits than patient pocketbooks," Public Citizen said. FirstWord spoke with Peter Maybarduk, Public Citizen's access to medicines director, and several other pricing policy experts to better understand the real-world impact — and savings — that might result from the MFN deals. For an in-depth look, see – Spotlight On: The MFN receipts are in — but experts still can’t see the bottom line.Pfizer to hand over some ex-US revenuesWhile the redactions make a real assessment of the deal economics difficult or impossible, the documents provide more information on how that MFN price might be set, as well as loopholes that biopharmas could use to avoid lowering their product price tags. In the case of Pfizer — the first pharma to ink an MFN deal — its definitive agreement with HHS spans Medicaid pricing through GENEROUS, a voluntary Centers for Medicare and Medicaid Services (CMS) model that links Medicaid net prices to those paid in selected foreign markets. However, certain terms in its agreement take precedence over the GENEROUS framework, meaning the detailed provisions may differ materially from what is known of the model.The contract further includes provisions covering newly launched drugs, direct-to-consumer discounts and a clause that will require Pfizer to share some of its spoils with HHS if it generates additional revenue from potential price increases outside the US.Pfizer also promised to invest in its US manufacturing capabilities, and in exchange, the Department of Commerce agreed not to impose pharmaceutical tariffs on the company's imports. "We stand by our belief that the agreement Pfizer voluntarily reached with the Administration last September is a win for American patients," a spokesperson told FirstWord in an email, citing lower-cost access without a middleman, efforts to mitigate Americans paying for a greater share of pharma R&D, and a more "stable and predictable environment" for US drugmakers. Lilly's agreement is more GLP-1 BALANCE, less GENEROUSUnder Lilly's agreement, the pharma secured a carveout to exclude most of its GLP-1–based drugs other than older diabetes treatment Trulicity (dulaglutide) from being subject to MFN pricing through the GENEROUS model. Instead, its key injectable tirzepatide products Mounjaro and Zepbound, along with oral drug Foundayo (orforglipron), fall under BALANCE — a voluntary CMS framework that negotiates lower pricing for certain GLP-1s under Medicare and Medicaid.In response to a request for comment, a Lilly spokesperson pointed to the company's voluntary agreement with the US government to expand Zepbound and Foundayo coverage through the Medicare GLP-1 Bridge programme, as well as lower-cost self-pay options through its direct-to-consumer LillyDirect platform. "These voluntary models succeed because they align government, manufacturer, plan and patient incentives around shared clinical and affordability goals, rather than imposing top-down price controls," the spokesperson told FirstWord in an email.For related analysis, see – Physician Views Results: Doctors ready to cross Medicare's GLP-1 bridge, but prior authorisation tollbooth looms.

22 Sep 2026

·www.pharmamanufacturing.com

Lilly breaks ground on $6.5B Houston API facility

Eli Lilly, headquartered in Indianapolis, has broken ground on a $6.5 billion active pharmaceutical ingredient (API) manufacturing facility in Houston, Texas. The site will produce Foundayo (orforglipron), the company’s synthetic oral GLP-1 medicine, along with other small molecule medicines and advanced therapeutics. The Houston facility is Lilly’s fifth U.S. API manufacturing location announced since 2020 and one of 10 U.S. manufacturing sites announced by the company during that period. The company said the site is part of a broader $50 billion investment in domestic medicine manufacturing capacity. Foundayo is a small molecule GLP-1 receptor agonist approved in the U.S. for weight management. Lilly said the Houston site also will manufacture oligonucleotides and other advanced therapeutics, expanding its production capabilities beyond conventional small-molecule medicines. Lilly expects the facility to employ more than 600 engineers, scientists, operations personnel and laboratory technicians. Construction is expected to create about 4,000 jobs, according to the announcement. The company is also providing $12.5 million to San Jacinto College to develop training pathways and expand equipment and facilities for advanced chemical synthesis manufacturing careers. The program will support training for technicians, operators, maintenance professionals, and other manufacturing personnel. Lilly is separately donating $2.5 million to the San Jacinto College Foundation for student scholarships. The site will incorporate machine learning, artificial intelligence, digitally integrated systems, and data analytics, with automation embedded throughout manufacturing operations, according to Lilly. The Houston project follows Lilly’s expanded manufacturing partnership with Resilience in Ohio. Announced in July, the $750 million investment will add production of Lilly’s injectable device for diabetes and obesity medicines at Resilience’s Cincinnati-area operations and is expected to create at least 400 jobs. Operations are targeted to begin in early 2027.

Oligonucleotide

100 Deals associated with Orforglipron

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United Kingdom	Eli Lilly & Co.	10 Aug 2026
Obesity	United States	Eli Lilly & Co.	01 Apr 2026
Overweight	United States	Eli Lilly & Co.	01 Apr 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	NDA/BLA	Canada	Eli Lilly Canada, Inc.	01 Jan 2026
Obesity, Abdominal	Phase 3	United States	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	China	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	Japan	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	Argentina	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	Czechia	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	Germany	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	India	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	Mexico	Eli Lilly & Co.	26 Aug 2026
Obesity, Abdominal	Phase 3	South Korea	Eli Lilly & Co.	26 Aug 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06045221 (ACHIEVE-3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	1,698	Orforglipron (12 mg Orforglipron)	yeviqrrcdj(rxpjkzplmr) = gzaxyqhrps fgaccbabjy (ckkhrzjkbl, 0.058) View more	-	15 Sep 2026
				Orforglipron (36 mg Orforglipron)	yeviqrrcdj(rxpjkzplmr) = sgupsqwivs fgaccbabjy (ckkhrzjkbl, 0.051) View more
NCT05872620 (ATTAIN-2, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Obesity	1,613	Placebo (Placebo)	qurimteltl(waonzfiyng) = mdrxjwwwfb wkoaftwdho (xpdzjuxviu, 0.215) View more	-	04 Sep 2026
				Orforglipron (6 mg Orforglipron QD)	qurimteltl(waonzfiyng) = wssvdsprre wkoaftwdho (xpdzjuxviu, 0.356) View more
NCT05869903 \| NCT05872620 (ATTAIN-2, Pubmed \| Obes Pillars)	Phase 3	Diabetes Mellitus, Type 2 \| Obesity	613	Orforglipron 5.5 mg	tvslbdkbol(qsmtwmgilx) = ujdtohceno efcscbkhut (ozuhmxrywp, -10.0 to -5.9)	Positive	01 Sep 2026
				Orforglipron 9 mg	tvslbdkbol(qsmtwmgilx) = wlevakhguy efcscbkhut (ozuhmxrywp, -13.4 to -9.3)
NCT05869903 (ATTAIN-1, CTgov)	Phase 3	Obesity	3,127	Placebo (Placebo)	qmhmoqlyjf(jgsnrkzwab) = lebzhuhznt flchtbngmy (eycyrgelsh, 0.247) View more	-	14 Aug 2026
				Orforglipron (6 mg Orforglipron)	qmhmoqlyjf(jgsnrkzwab) = ijcxsjolrp flchtbngmy (eycyrgelsh, 0.302) View more
NCT06109311 (Pubmed \| JAMA)	Phase 3	Diabetes Mellitus, Type 2	546	Orforglipron 3 mg once daily + Orforglipron 3 mg once daily	kntchayufs(xjdeohnmno) = xqjmpafzkm lbidsdextj (zpuvbrbgxc ) View more	Positive	04 Aug 2026
				Orforglipron 12 mg once daily + Orforglipron 12 mg once daily	kntchayufs(xjdeohnmno) = dpiscgjvbs lbidsdextj (zpuvbrbgxc ) View more
NCT05931380 (ATTAIN-J, CTgov)	Phase 3	Obesity	238	Placebo (Placebo QD)	topblhyvnw(tgszumnwwl) = lzsesnnzsu jhymblpzkl (keowibxiwm, 0.732) View more	-	20 Jul 2026
				Orforglipron (6 mg Orforglipron QD)	topblhyvnw(tgszumnwwl) = zxfxhvsfik jhymblpzkl (keowibxiwm, 0.866) View more
NCT06370728 (CTgov)	Phase 1	-	30	Orforglipron+Carbamazepine	tcapuuipdb(ezqznotprj) = kinfbqlqyh cmmbysyeyi (djjkaujmcw, 26.6) View more	-	17 Jul 2026
NCT06023095 (CTgov)	Phase 1	Obesity	24	LY3502970 (LY3502970 (Cohort 1))	ytlcthraij = gxlgkhpmgz kowzotxnjh (tqswztxbxs, ynfnrfqvdm - eskdrsrqhn) View more	-	17 Jul 2026
				LY3502970 (LY3502970 (Cohort 2))	ytlcthraij = lcrbwiyzvm kowzotxnjh (tqswztxbxs, rdtjtdinfu - iegojxefxo) View more
NCT06192108 (ACHIEVE-2, Pubmed \| Lancet)	Phase 3	Diabetes Mellitus, Type 2	962	Orforglipron 3 mg	kmxexnwgno(ypnrxvemtr) = eshvsjyblm ooorukkgpk (mdbgejoazd ) View more	Positive	01 Jul 2026
				Orforglipron 12 mg	kmxexnwgno(ypnrxvemtr) = fijrnxxktv ooorukkgpk (mdbgejoazd ) View more
NCT06010004 (ACHIEVE-J, CTgov)	Phase 3	Diabetes Mellitus, Type 2	401	Orforglipron (3 mg Orforglipron)	wmgpxkyimn = vlefrlltno kgdwndnjua (coosbbpcnx, nwsmkjiobl - cvlpnsnwjo) View more	-	30 Jun 2026
				Orforglipron (12 mg Orforglipron)	wmgpxkyimn = lhhyatsysi kgdwndnjua (coosbbpcnx, nmtwqcfljx - ihfkbnksdv) View more

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