HQ Team
October 11, 2023: Dutch pharmaceutical company, Novo Nordisk, has stopped testing Ozempic to treat the progression of renal impairment in people with type 2 diabetes and chronic kidney disease after the interim results met certain pre-specified” criteria for efficacy.
The company’s decision was based on a recommendation from the independent Data Monitoring Committee, which concluded that the results from an “interim analysis met certain pre-specified criteria” for stopping the trial early for efficacy.
The company’s process of closing the trial would be initiated and “to protect the integrity of the trial, Novo Nordisk remains blinded to the results until trial completion,” which is expected by the first half of 2024, according to an emailed statement.
The experiment was initiated in 2019 to compare injectable semaglutide (branded as Ozempic) 1.0 mg with placebo as an adjunct to standard care treatment. More than 3,500 people enrolled in the trial which was conducted in 28 countries at more than 400 investigator sites.
Delay in progression
The key objective of the trial was to demonstrate delay in the progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoints.
“The trial protocol provides for an interim analysis when a pre-specified number of primary endpoint events has occurred,” according to the statement.
Once-weekly semaglutide injection was approved in 2017 by the FDA in 0.5, 1.0 and 2.0 mg, doses under the company’s brand name Ozempic,. It is meant to be used as a supplement to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
It also reduces the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, according to a company statement. Semaglutide is also an active ingredient in the company’s weight-loss drug Wegovy.
Lower sugar levels
Ozempic helps lower blood sugar by helping the pancreas make more insulin. It is not approved for weight loss, but some physicians prescribe it to be used for weight loss. It works by mimicking a naturally occurring hormone.
As those hormone levels rise, the molecules go to your brain, telling it you’re full. It also slows digestion by increasing the time it takes for food to leave the body. This is similar to the effect of bariatric surgery.
When using Ozempic to treat diabetes, weight loss is a common side effect. It is designed to be taken long-term.
