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PubMed1 Apr 2026Obesity reviews : an official journal of the International Association for the Study of Obesity● 2/10i

How Bioethics and Reproductive Justice Ought to Inform Glucagon-Like Peptide-1 Receptor Agonists, Research, and Pregnancy.

Pondugula N, Merriam AA

Bioethics researchers argue that pregnant people are systematically excluded from GLP-1 receptor agonist studies, creating evidence gaps that prevent understanding of safety and efficacy during pregnancy. Theoretical framework analysis applying reproductive justice principles to GLP-1RA research methodology. This highlights a regulatory and commercial challenge facing all GLP-1RA manufacturers as pregnancy safety data remains limited across the drug class.

Strategic Signal

FDA pregnancy labeling requirements for GLP-1RAs remain unchanged without actual clinical data. This theoretical framework could influence future trial design discussions at advisory committee meetings, but regulatory agencies prioritize clinical evidence over ethical positioning papers. The practical impact on Novo Nordisk and Eli Lilly's pregnancy research strategies depends on whether bioethics committees at major academic centers adopt these frameworks when reviewing protocols.

GLP-1

Original Abstract

There are large evidence gaps for pregnant people, and research in pregnancy should be prioritized to ensure strong evidence to guide safe clinical practice. GLP-1 receptor agonist (GLP-1RA) research is a modern example that shows how pregnancy continues to preclude individuals from participating in and subsequently receiving potential benefits of research or understanding their important effects. In this article, we utilize GLP-1RAs to practically discuss prior ethical work on research in pregnancy, we specifically apply Miranda Waggoner and Anne Lyerly's framework of the protectionist ethic to the case of GLP-1RA research, and we consider risk as well as potential maternal and fetal benefit as they relate to GLP-1RAs. Finally, reproductive justice as an organizing theoretical framework offers many important insights into critically evaluating research, pregnancy, and GLP-1RAs and should be centered throughout research in pregnancy efforts. Strong ethical analyses, rooted in reproductive justice, are critical to informing clinical science in pregnant humans to narrow the evidence gaps, including with GLP-1RAs.

Related signals

Strategic Signal

FDA1 Apr 2026New Drug Approval (NDA/BLA)High impact● 10/10i

FDA Approves Foundayo (Orforglipron) — New Drug Approval (NDA/BLA)

FDA approved orforglipron (Foundayo, Eli Lilly) for type 2 diabetes -- a once-daily oral small-molecule GLP-1 receptor agonist. Orforglipron is the first non-peptide oral GLP-1 approved in the US; oral semaglutide (Rybelsus, Novo Nordisk) has been approved for T2D since 2019 and expanded to obesity in January 2026. Unlike Rybelsus, orforglipron requires no fasting or water volume restrictions before dosing.

GLP-1Type 2 diabetesPricing/accessEli LillyNovo Nordisk

Strategic Signal

Clinical Trial19 Mar 2026Phase 3High impact● 9/10i

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Phase 3 SURMOUNT-1 tests once-weekly tirzepatide at three doses versus placebo in adults without type 2 diabetes who have obesity or are overweight with comorbidities. The randomized, double-blind trial targets 2,539 participants with primary efficacy assessment at 72 weeks. This represents tirzepatide's pivotal obesity trial against placebo, potentially supporting Eli Lilly's bid to compete directly with Wegovy in the non-diabetic obesity market. A prediabetes subgroup continues long-term to assess diabetes prevention.

Weight lossGLP-1Eli Lilly

Strategic Signal

Clinical Trial17 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Phase 3 open-label trial compared once-daily oral orforglipron versus insulin glargine in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study enrolled 2,749 participants with primary endpoint of time to first major adverse cardiovascular event, completed in March 2026. Eli Lilly is positioning orforglipron as a cardiovascular outcomes option in high-risk populations, directly competing with established insulin therapy in this indication. This represents the first cardiovascular outcomes trial for orforglipron following its April 2026 FDA approval for type 2 diabetes.

GLP-1Type 2 diabetesWeight lossCardiovascularEli Lilly

Strategic Signal

Clinical Trial13 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity

Eli Lilly is conducting a Phase 3 head-to-head trial comparing retatrutide versus tirzepatide in adults with obesity. The double-blind study targets 800 participants over 89 weeks with primary endpoint of percent body weight change, completing December 2026. This represents the first direct comparison between Eli Lilly's next-generation triple receptor agonist retatrutide and its approved dual agonist tirzepatide in obesity. The trial positions Eli Lilly to potentially establish superiority claims for retatrutide ahead of expected regulatory submissions.

GLP-1Weight lossDrug comparisonsEli Lilly

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