Novo Nordisk Testing Pill Version of Ozempic, Wegovy for Weight Loss

Novo Nordisk is in the process of conducting clinical trials on a pill version of Wegovy, a weight loss drug that contains the same active ingredient as the diabetes treatment Ozempic, in hopes of drawing in more potential consumers with a non-injectable version of the medication.

Last week, Novo Nordisk presented early clinical trial data (PDF) on Amycretin, an experimental daily weight loss pill, which works similarly to Ozempic and Wegovy, as a glucagon-like peptide-1 (GLP-1) receptor agonist, but also includes pancreas hormones that reduce feelings of hunger and does not require a weekly shot.

The drug maker indicated that participants receiving the proposed diet pill experienced significant reduction in body weight after three months of use, according to a presentation at the European Association for the Study of Diabetes.

The diet pill is the latest effort by the manufacturer to capitalize on the success of Ozempic, which is marketed for treatment of diabetes, but has become one of the top-selling drugs in the U.S. based on “off-label” use as a diet drug.

Given the effectiveness of Ozempic promoting weight loss, Novo Nordisk previously introduced Wegovy in 2021, which contains the same active ingredient, semaglutide, but is specifically approved by the FDA for weight loss.

Although the drugs have been aggressively marketed as safe and effective, Novo Nordisk now faces a growing number of Ozempic lawsuits and Wegovy lawsuits being filed by users left with devastating long-term gastrointestinal problems, like gastroparesis or bowel obstructions, claiming that the drug maker placed a desire for profits before consumer safety by withholding information about the potential side effects.

Currently, both Ozempic and Wegovy are introduced to the body through injections, which gives some consumers pause. However, Novo Nordisk hopes a daily pill like Amycretin will pull in those who may be squeamish about regularly sticking themselves with needles.

The company indicates that it has conducted a phase 1 clinical trial which found that Amycretin users lost more than 13% of their body weight in only three months. However, the drug also showed signs of similar gastrointestinal side effects as Ozempic and Wegovy, including nausea and vomiting.

The trial involved 60 participants, and there was only one serious adverse event reported. However, users reported about 242 mild or moderate complications with Amycretin, largely involving gastrointestinal side effects also linked to Ozempic and Wegovy.

Novo Nordisk indicates the findings have cleared the way for continued testing and development of the weight loss pill. However, it is unclear when or if Amycretin will be approved for weight loss use by the U.S. Food and Drug Administration.

Ozempic and Wegovy Stomach Paralysis Risks

Novo Nordisk is releasing the findings amid growing awareness among consumers and the medical community about the risk of gastroparesis from Wegovy, Ozempic and similar drugs when used for weight loss, which could erode sales as more users learn about the potential side effects.

Gastroparesis, also known as delayed gastric emptying or stomach paralysis, weakens the normal muscle movement in the stomach. These stomach contractions are necessary to push food through the digestive tract.

When gastroparesis occurs, the stomach is slow to empty, resulting in symptoms including nausea, vomiting undigested food, abdominal pain, abdominal bloating, severe dehydration, feeling full after only a few bites, undigested food hardening in the stomach, acid reflux, fluctuating blood sugar levels, lack of appetite, weight loss, malnutrition and decreased quality of life. However, some users are reporting these side effects persist long after Wegovy or Ozempic are discontinued.

September 2024 Ozempic and Wegovy Lawsuits Update

Given common questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Ozempic, Wegovy and other GLP-1 lawsuits earlier this year, transferring complaints to the U.S. District Court for the Eastern District of Pennsylvania, where U.S. District Judge Karen S. Marston is presiding over coordinated discovery.

As part of the management of the MDL, Judge Marston has indicated that before any individual cases are prepared for trial, the Court will address a number of “cross cutting” issues in the litigation, which may impact a large number of claims. Therefore, early discovery and motions will focus on addressing whether the claims are pre-empted by federal law, and whether plaintiffs must provide specific gastroparesis diagnostic testing evidence in the Ozempic and Wegovy lawsuits.

In addition, the court is still considering whether the first phase of discovery will also include an examination of the general evidence that Ozempic and Wegovy cause stomach paralysis, or whether challenges to the admissibility of expert witness testimony will be addressed during the work up of individual bellwether claims for trial.