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

We are conducting a research study to learn 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, you will receive detailed metabolic testing and may receive study results that provide additional information about your blood sugar and metabolic health.

Start Date01 Oct 2026

Sponsor / Collaborator

The Massachusetts General Hospital

NCT07668336

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.
Participation in the study will last about 61 weeks.

Start Date01 Sep 2026

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Aug 2026·DIABETES OBESITY & METABOLISM

Oral Semaglutide 25 mg Versus Orforglipron 36 mg in Obesity: A Population‐Adjusted Indirect Treatment Comparison

Article

Author: Bøg, Martin ; Cowley, Phoebe ; Michalak, Wojciech ; Laugesen, Christian ; Bendixen, Theiss ; Rathor, Naveen ; Kushner, Robert F. ; Chowdhury, Rohan

ABSTRACT:

Aims:

This study aimed to indirectly compare the effects of oral semaglutide 25 mg versus orforglipron 36 mg on body weight loss, other cardiometabolic biomarkers, and tolerability in adults with overweight (body mass index [BMI] ≥ 27 kg/m 2 and at least one obesity‐related complication) or obesity (BMI ≥ 30 kg/m 2 ), without diabetes, using data from OASIS 4 and ATTAIN‐1.

Materials and Methods:

Individual patient data from OASIS 4 and aggregate data from ATTAIN‐1 informed anchored indirect treatment comparisons (ITCs). Baseline differences in sex, body weight and normoglycaemic status were adjusted for using population‐adjustment methods. Efficacy (percentage body weight change, categorical body weight loss thresholds, other cardiometabolic biomarkers) and tolerability outcomes (treatment discontinuation due to any adverse event [AE] and due to gastrointestinal [GI] AEs) were analysed.

Results:

Population‐adjusted analyses showed a significantly greater percentage change from baseline in body weight with oral semaglutide 25 mg than with orforglipron 36 mg, with mean differences (MDs) of −3.2%‐points (95% confidence intervals [CIs]: −5.9, −0.4; treatment‐regimen estimand) and −3.0%‐points (95% CI: −5.8, −0.3; efficacy estimand). Discontinuation was higher with orforglipron (due to any AE: odds ratio [OR]: 4.1 [95% CI: 1.3, 13.0] and due to GI AEs: OR: 13.9 [95% CI: 2.0, 96.0]).

Conclusions:

In this ITC, oral semaglutide 25 mg was associated with greater body weight loss and fewer discontinuations due to any AEs and due to GI AEs compared with orforglipron 36 mg. These findings provide insight into the comparative effectiveness and tolerability in the absence of head‐to‐head clinical trials.

01 Jul 2026·LANCET

Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial

Article

Author: Wasilewska, Katarzyna ; Khalsa, Satkirin ; De Los Rios Ibarra, Manuel ; Romero-Ibarguengoitia, Maria Elena ; Jia, Weiping ; Lugowski, Tomasz ; Connery, Lisa ; Wilson, Jonathan ; Wu, Wen-Shuo ; Lin, Tsung-Hsien ; Chiang, Chern-En ; Matian, Arash ; Lopez Rosas, Enrique ; Topiwala, Shehzad ; Witzel, Peter ; Rosenstock, Julio ; Liu, Rong ; Gumprecht, Janusz ; García, Elías ; Schaum, Thomas ; Soufer, Joseph ; Napora, Piotr ; Dong, Xiaolin ; Shi, Bimin ; Chen, Yanyun ; Zeller, Helga ; Gonzalez Galvez, Guillermo ; Vutikullird, Apinya ; Kirby, John ; Chu, Chih-Hsun ; Liu, Dexue ; Ou, Horng-Yih ; del Pino, Pedro Orozco ; Vega, Damaris ; Yuan, Guoyue ; Momoyama, Yoko ; Lazcano Soto, José ; Skokowska, Ewa ; Wang, Jun-Sing ; Rose, Ludger ; Reynolds, Steven ; Siewko, Katarzyna ; Eifu, Michele ; Smolen, Agata ; Ma, Jianhua ; Xu, Yushan ; Sauque Reyna, Leobardo ; Wang, Chih-Yuan ; Mendez Machado, Gustavo ; Khaleghi, Behnam ; Vidal Tamayo Ramirez, Rafael ; Rudolph, Justen ; Kirsch, Bastian ; Li, Qingju ; Kwiatkowska, Magdalena ; Yu, Haoyong ; Staudenmeyer, Andreas ; Zhu, Hong ; Mills, Richard ; Forst, Thomas ; Fatakia, Adil ; Welch, Michelle ; Mlodawska-Choluj, Dorota ; Chasteen, Jeffrey ; Pei, Dee ; Beesley, Brian ; Denning, Max ; Cheng, Zhi Feng ; Lu, Yibing ; Chen, Jung-Fu ; García, Pedro ; Lorra, Babette ; Szyprowska, Ewa ; Segner, Alexander ; Schaefer, Axel ; Jozefowska, Malgorzata ; Wenzl-Bauer, Veronika ; Zambrano Ruiz, Eduardo ; Ye, Jun ; Gomez-Samano, Miguel ; Li, Jianghao

BACKGROUND:

Type 2 diabetes is a complex metabolic disorder often requiring combination therapy for optimal glycaemic control. This study assessed the efficacy and safety of orforglipron, an oral, non-peptide GLP-1 receptor agonist, versus dapagliflozin, an oral SGLT2 inhibitor, in participants with type 2 diabetes and inadequate glycaemic control with metformin.

METHODS:

This 40-week, phase 3, multicentre, open-label (orforglipron dose-blinded), randomised study was conducted in 73 sites across six countries. The study included adults with type 2 diabetes using metformin (≥1500 mg/day) with glycated haemoglobin (HbA_1c) concentrations between 7·0% and 10·5% (53-91 mmol/mol), stable bodyweight (±5%), and a BMI of 23·0 kg/m² or more. Participants were randomly assigned in a 1:1:1:1 ratio to receive once-daily oral orforglipron (3 mg, 12 mg, or 36 mg) or dapagliflozin 10 mg. The primary endpoint was change from baseline in HbA_1c at week 40, using a non-inferiority margin of 0·3% for orforglipron versus dapagliflozin; analysis was based on the treatment-regimen estimand (data obtained regardless of study intervention discontinuation or initiation of additional glucose-lowering agents). The treatment regimen estimand was the primary estimand, with the efficacy estimand considered supportive. Safety was assessed in all randomised participants who received at least one dose of study drug. This trial is registered at ClinicalTrials.gov (NCT06192108, completed).

FINDINGS:

From Jan 10, 2024, to Sept 26, 2025, 1404 adults were assessed and 962 participants were randomly assigned to orforglipron 3 mg (n=240), 12 mg (n=241), or 36 mg (n=241), or dapagliflozin 10 mg (n=240). The baseline population included 474 (49%) females and had a mean age of 56·1 years (SD 11·5), HbA_1c of 8·14% (1·04), type 2 diabetes duration of 8·0 years (6·7), and BMI of 32·6 kg/m² (6·6). At week 40, for the treatment regimen estimand, all orforglipron doses were non-inferior to dapagliflozin in reducing HbA_1c. Change from baseline in mean HbA_1c was -1·23% (SE 0·08), -1·50% (0·08), and -1·56% (0·09) with orforglipron 3 mg, 12 mg, and 36 mg, respectively, versus -0·81% (0·07) with dapagliflozin 10 mg; estimated treatment difference versus dapagliflozin was -0·42% (95% CI -0·62 to -0·23), -0·70% (-0·90 to -0·49), and -0·75% (-0·96 to -0·55) with orforglipron 3 mg, 12 mg, and 36 mg, respectively (all p<0·0001). The most frequent adverse events associated with orforglipron were mild-to-moderate gastrointestinal events, observed in 112 (47%) of 240 participants receiving orforglipron 3 mg, 112 (46%) of 241 receiving 12 mg, and 130 (54%) of 241 receiving 36 mg, versus 29 (12%) of 240 receiving dapagliflozin. More study intervention discontinuations were observed with orforglipron 3 mg (35 [15%] of 240), 12 mg (44 [18%] of 241), and 36 mg (47 [20%] of 241) than with dapagliflozin (14 [6%] of 240). No severe episode of hypoglycaemia was reported.

INTERPRETATION:

Orforglipron demonstrated superior glycaemic control compared with dapagliflozin, with a tolerability profile consistent with the GLP-1 receptor agonist class, including increased rates of discontinuation due to adverse events, positioning it as a potential effective oral treatment option for type 2 diabetes.

FUNDING:

Eli Lilly and Company.

01 Jul 2026·NATURE MEDICINE

Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial

Article

Author: Chao, Ariana M ; Xie, Cathy ; Halpern, Bruno ; Aronne, Louis J ; Horn, Deborah B ; Valderas, Elisa Gomez ; Xavier, Neena ; le Roux, Carel W ; Ribeiro, Anderson ; Hyman, David M ; Griffin, Ryan ; Lee, Clare J ; Glass, Leonard ; Ho, Wayne

Abstract:

Incretins have improved the management of obesity and its related complications, but maintaining these health benefits requires ongoing administration, which can be challenging. Orforglipron, a once-daily oral nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated weight loss efficacy, improvements in cardiometabolic risk factors, and safety generally similar to injectable GLP-1 receptor agonists. Here this double-blind, placebo-controlled trial randomized participants previously treated with tirzepatide (cohort 1: N = 205) or semaglutide (cohort 2: N = 171) during the SURMOUNT-5 study to orforglipron once daily or placebo. Cohort 1 participants who achieved body weight plateau maintained a model-based estimate (MBE) of 74.7% (s.e.m. 4.05) of body weight reduction with orforglipron compared with an MBE of 49.2% (s.e.m. 3.92) with placebo, resulting in an estimated treatment difference of MBE 25.5% (95% confidence interval 14.5 to 36.5); P < 0.001; treatment-regimen estimand) at week 52. Cohort 2 participants who achieved body weight plateau maintained an MBE of 79.3% (s.e.m. 4.42) of body weight reduction with orforglipron compared with an MBE of 37.6% (s.e.m. 7.46) with placebo, resulting in an estimated treatment difference of MBE 41.7 (95% confidence interval 24.4 to 59.0); P < 0.001; treatment-regimen estimand) at week 52. All key secondary endpoints were met. The most common adverse events were gastrointestinal effects, which were mostly mild to moderate in severity. These data demonstrate orforglipron’s potential as a globally scalable option for minimizing weight changes after injectable therapy. Trial limitations include the absence of a comparator arm involving continued use of injectable obesity-management medications and the trial’s 1-year duration. ClinicalTrials.gov registration: NCT06584916 .

403

News (Medical) associated with Orforglipron

12 Aug 2026

·www.biospace.com

Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight

After two rejections, Replimune has made it across the regulatory finish line with its twice-rejected therapy for advanced melanoma. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart > Watch on YouTube After a drama-filled year that included two FDA rejections, Replimune has finally secured market approval for its oncolytic immunotherapy RP1 to treat advanced melanoma. The greenlight came after a contentious advisory committee meeting and after its scheduled PDUFA date, but analysts think RP1—to be sold as Tudriqev—could reach peak sales of $1.3 billion . In its second quarter earnings, Eli Lilly reported revenue of $23 billion , a 48% increase over Q2 2025. However, the pharma’s oral GLP-1 Foundayo is not selling as well as Novo Nordisk’s oral Wegovy. Foundayo took in $98 million for its first quarter on the market, while Novo previously reported $355 million for the Wegovy pill in Q1 after its December approval. Next up, Lilly’s next-generation obesity asset, retatrutide , which is currently at the heart of a legal dispute between the FDA and Lilly over whether it should be classified as a biologic. Meanwhile, Novo addressed various recent setbacks on its second quarter earnings call, including two head-to-head trials pointing to the superiority of Lilly’s assets and the late-stage IL-6 fail reported last week. BioSpace also covered earnings from Gilead , Amgen , BioMarin and Denali , among others. Finally, Compass Pathways and Definium Therapeutics both anticipate near-term catalysts . This comes as the federal focus government throws its support behind the space —and works to “curb psychiatric overprescribing.” Also check out what Insilico Medicine CEO Alex Zhavoronkov has to say about how he built the AI drug hunter into one of pharma’s most-sought after partners.

Drug ApprovalImmunotherapyClinical Result

12 Aug 2026

·allsci.com

United Labs' oral GLP-1 drug cleared for US trials

An oral, non-peptide GLP-1R agonist from China-based United Laboratories (HKEX: 03933) is set to enter human testing in the US after the US FDA cleared UBT48128 for studies in obesity and type 2 diabetes. As per United Labs' announcement, UBT48128 is an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that will be developed in the US by wholly-owned subsidiary United Bio-Technology (Hengqin) Co., Ltd. UBT48128 activates the GLP-1 receptor via a non-peptide small-molecule mechanism, stimulating glucose-dependent insulin secretion, suppressing glucagon release, and modulating appetite and energy metabolism. The oral tablet formulation distinguishes it from the dominant injectable GLP-1R agonists on the market. The company said preclinical studies across multiple animal models demonstrated reductions in body weight and blood glucose, and asserted superior weight-loss efficacy compared to currently marketed products in the same category. The competitive pressure in oral GLP-1R agonism has intensified considerably. Eli Lilly's orforglipron (Foundayo), a non-peptide small-molecule GLP-1R agonist, received FDA approval for chronic weight management in 2026 and represents the most direct mechanistic comparator for UBT48128 in the obesity indication. Novo Nordisk's oral semaglutide (Rybelsus), a peptide-based GLP-1R agonist formulated with a sodium N-[8-(2-hydroxybenzoyl) aminocaprylate absorption enhancer, remains the only approved oral GLP-1R agonist for type 2 diabetes. Injectable agents — including Novo Nordisk's semaglutide (Wegovy, Ozempic) and Eli Lilly's tirzepatide (Zepbound, Mounjaro) — continue to set the efficacy benchmark, with tirzepatide delivering approximately 20% mean body weight reduction in pivotal obesity trials. United Laboratories' broader GLP-1 pipeline includes UBT251, a GLP-1/GIP/glucagon triple receptor agonist that was licensed to Novo Nordisk in March 2025 in a deal valued at up to USD 2 billion and is currently in Phase III development. UBT48128 represents a distinct modality — oral, small-molecule — and an earlier development stage, with the IND clearances marking the transition from preclinical to clinical evaluation. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Drug ApprovalINDPhase 3Phase 2

11 Aug 2026

·pmlive.com

Eli Lilly’s Foundayo authorised by UK MHRA for weight loss and type 2 diabetes

Eli Lilly’s Foundayo (orforglipron) has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for weight loss and type 2 diabetes, with the UK being the first country in Europe to approve the GLP-1 tablet. Foundayo is a GLP-1 receptor agonist. It works by mimicking the action of a naturally occurring hormone, glucagon-like peptide (GLP-1), which is released by the body after eating. Foundayo acts on areas of the brain that regulate appetite, helping people feel fuller for longer, reducing hunger and decreasing food cravings. As a result, it can help people eat less and support weight reduction alongside appropriate diet and lifestyle measures. In people with type 2 diabetes, Foundayo also reduces the levels of sugar in the body when the levels of sugar are high. Alongside a reduced-calorie diet and increased physical activity, Foundayo is authorised for weight loss and weight maintenance in adults in the UK with a BMI of 30 or above, or a BMI of between 27 and 30, and at least one weight-related comorbidity. It is also authorised to improve glycaemic control for patients with insufficiently controlled type 2 diabetes. The tablet is taken once daily and can be taken at any time of day with no food or water restrictions. Treatment begins at 0.8 mg, escalating through 2.5 mg, 5.5 mg, 9 mg, 14.5 mg and 17.2 mg, with a minimum of one month at each dose level. The most common side effects for those taking orforglipron are nausea, constipation, diarrhoea, vomiting, dyspepsia (indigestion) and abdominal pain. Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said: “Following rigorous assessment of orforglipron’s safety, quality and effectiveness, we are pleased to be the first regulator in Europe to authorise this tablet for weight management and type 2 diabetes. “As with all GLP-1 receptor agonists, this is a prescription-only medication, and the MHRA will keep the safety and effectiveness of orforglipron under close review.” While Foundayo has been approved for use in the UK, it is not available currently through the NHS. As with all new treatments, an evaluation by the National Institute for Health and Care Excellence (NICE) will follow.

Drug Approval

100 Deals associated with Orforglipron

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
Carotid Artery Diseases	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Carotid Artery Diseases	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Carotid Artery Diseases	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05931380 (ATTAIN-J, CTgov)	Phase 3	Obesity	238	Placebo (Placebo QD)	wxshzwxevm(mhtegoiiks) = zbparlnfkc bzalkassdc (whgmnnrxzn, 0.732) View more	-	20 Jul 2026
				Orforglipron (6 mg Orforglipron QD)	wxshzwxevm(mhtegoiiks) = okaxvncvld bzalkassdc (whgmnnrxzn, 0.866) View more
NCT06023095 (CTgov)	Phase 1	Obesity	24	LY3502970 (LY3502970 (Cohort 1))	scsnegkkcm = uancmrodno sabchzbahx (uvcoiitaqx, dhcljiyrnb - dagcaoaqyk) View more	-	17 Jul 2026
				LY3502970 (LY3502970 (Cohort 2))	scsnegkkcm = jhkktxpawn sabchzbahx (uvcoiitaqx, lphywjamip - sydhkgpvxt) View more
NCT06370728 (CTgov)	Phase 1	-	30	Orforglipron+Carbamazepine	iowwdcekrq(tysxnrxcts) = bxkuwwohne qnfpybbqhj (xlqrrghsfd, 26.6) View more	-	17 Jul 2026
NCT06192108 (ACHIEVE-2, Pubmed \| Lancet)	Phase 3	Diabetes Mellitus, Type 2	962	Orforglipron 3 mg	cjgtlyjvxq(sqirbbtiwx) = ikekulycjm guvsxdzlvd (riryouwzhh ) View more	Positive	01 Jul 2026
				Orforglipron 12 mg	cjgtlyjvxq(sqirbbtiwx) = oqfsdrlcst guvsxdzlvd (riryouwzhh ) View more
NCT06010004 (ACHIEVE-J, CTgov)	Phase 3	Diabetes Mellitus, Type 2	401	Orforglipron (3 mg Orforglipron)	ikxnfeszyl = uqtmxjbwck gpbwrgdinx (jccaejdowd, yqcrwnjqcz - trjhclzims) View more	-	30 Jun 2026
				Orforglipron (12 mg Orforglipron)	ikxnfeszyl = uyqjypfxzq gpbwrgdinx (jccaejdowd, bvfcjvpqmr - scmxhabsab) View more
NCT06023095 (ADA2026)	Phase 1	Overweight \| Obesity	24	Orforglipron	emaalmcbdq(wwmuwmsjpy) = zfktfvwcgy rpikvyczdp (ueesevvfwj ) View more	Positive	20 Jun 2026
NCT06192108 (ACHIEVE-2, ADA2026)	Phase 3	Diabetes Mellitus, Type 2	962	Orforglipron 3 mg	qwwcawdmqf(ufcfbntwyw) = Treatment discontinuations due to GI AE were 5.8-8.3% with OFG and 0.4% with DAPA. mvowtajjco (jtpnuqhrnd ) View more	Positive	20 Jun 2026
				Orforglipron 36 mg
NCT05936138 (CTgov)	Phase 1	Renal Insufficiency \| Kidney Failure, Chronic	24	LY3502970 (LY3502970 (Normal Renal Function))	galuohwlii(fyimmgfpjh) = ftstdfkibo ehaxstrhie (ndoxvewivf, 32.1) View more	-	09 Jun 2026
				LY3502970 (LY3502970 (Severe Renal Impairment))	galuohwlii(fyimmgfpjh) = afwwqahdce ehaxstrhie (ndoxvewivf, 48.6) View more
NCT05341089 (CTgov)	Phase 1	-	39	LY3502970 (16 mg LY3502970 (Formulation 1))	xttrjrdcpg(agvxkgwhos) = hkllfdlgwn txwtvulick (snyhhakedi, 40) View more	-	27 May 2026
				LY3502970 (16 mg LY3502970 (Formulation 2))	xttrjrdcpg(agvxkgwhos) = fxoeuqdldh txwtvulick (snyhhakedi, 43) View more
NCT06085482 (CTgov)	Phase 1	-	10	LY3502970	ninipitsgb(wmdpwhxvgl) = iksdgnxmlx hysgmkxkop (jegaulgtgw, 27) View more	-	27 May 2026

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