ALDERIA INTELLIGENCE
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PubMed1 Apr 2026·Obesity 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

FDA1 Apr 2026·New Drug Approval (NDA/BLA)● 10/10iHigh impact

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.

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ClinicalTrials19 Mar 2026·Phase 3● 9/10iHigh impact

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
ClinicalTrials17 Apr 2026·Phase 3● 8/10iHigh impactPick of the week

The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

Phase 3 trial evaluates semaglutide versus placebo in adults with non-cirrhotic NASH, measuring steatohepatitis resolution, fibrosis improvement, and cirrhosis-free survival over approximately 5 years. The study enrolled 1,205 adults and is active but not recruiting, with completion expected in 2029. This represents Novo Nordisk's push into NASH, a major unmet need with no approved GLP-1 therapies despite strong preclinical rationale. The trial's dual primary endpoints and 5-year duration suggest preparation for a pivotal regulatory filing in this large addressable market.

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ClinicalTrials17 Apr 2026·Phase 3● 8/10iHigh impact

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Phase 3 trial evaluating retatrutide for chronic low back pain in people with obesity or overweight, targeting dual primary endpoints of pain intensity reduction and weight loss. 586-person placebo-controlled study expected to complete September 2027, investigating a novel indication beyond traditional metabolic endpoints. Eli Lilly is exploring pain management as a potential expansion for their triple agonist, representing the first major trial of a GLP-1-based therapy specifically for chronic pain conditions.

GLP-1Weight lossOtherEli Lilly

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