(Updates to add Novo's Alzheimer trial failure)
By Patrick Wingrove
Nov 24 (Reuters) -
Novo Nordisk said an older version of its
weight-loss drug semaglutide failed to meet its main goal in
late-stage trials testing whether the medicine can slow
cognitive decline in Alzheimer's patients.
The results is a blow to hopes that Alzheimer's could
open a major new market for GLP-1 medicines such as semaglutide,
as Novo faces rising competition to its blockbuster drugs in its
core treatment areas of obesity and diabetes.
The drug tested was Rybelsus, a pill approved only for
type 2 diabetes. Like Novo's blockbusters Ozempic and Wegovy, it
contains semaglutide.
Here are some of the other conditions the drugs are being
used and tested for:
Alcohol addiction
* A study conducted by the University of Copenhagen's
Psychiatric Centre Rigshospitalet is investigating whether
semaglutide - the main ingredient in Wegovy and Ozempic - can
help reduce alcohol intake in 108 patients diagnosed with
alcohol use disorder and obesity.
Alzheimer's disease
* Novo Nordisk said an older version of semaglutide, branded
Rybelsus, failed to slow cognitive decline in early-stage
Alzheimer's patients in two trials, covering a combined 3,808
patients.
Cardiovascular disease
* Eli Lilly ( LLY ) was testing tirzepatide - the main ingredient in
Mounjaro and Zepbound - for patients with heart failure and
obesity. Lilly had said it would enroll about 700 people in the
study, but the company said in May that it has withdrawn its
U.S. application for heart failure approval.
* Novo won the U.S. Food and Drug Administration's approval in
2024 to use Wegovy to reduce the risk of cardiovascular death,
heart attack and stroke in overweight or obese adults without
diabetes.
* The European Medicines Agency backed the use of Novo's
semaglutide to help ease heart failure symptoms in people with
obesity in September 2024.
Chronic kidney disease
* Novo's Ozempic is approved in the United States for reducing
the risk of kidney failure and disease progression as well as
the risk of death due to heart problems in diabetes patients
with chronic kidney disease.
* Lilly's tirzepatide is being evaluated in a mid-stage study
of patients with chronic kidney disease and obesity. Lilly plans
to enroll up to 140 participants with the study expected to be
completed next year.
Liver disease
* Novo's Wegovy in August became the first GLP-1 therapy
approved in the U.S. to treat adults with metabolic
dysfunction-associated steatohepatitis, or MASH, based on
results from the first part of its late-stage trial. Results
from the second part, with about 1,200 patients, is expected in
2029.
* Lilly's tirzepatide in February helped up to 74% of patients
achieve absence of MASH with no worsening of liver scarring at
52 weeks, compared with 13% of patients on placebo, in a
mid-stage trial.
Neurological disorders
* Researchers at the Danish Headache Center are testing
semaglutide along with a very low calorie diet as a treatment
for new-onset idiopathic intracranial hypertension, a condition
associated with obesity in which blood pressure inside the head
rises. The study has enrolled about 50 patients and is expected
to complete in October 2025.
Sleep apnea
* Zepbound was approved by the U.S. Food and Drug
Administration for obstructive sleep apnea in December 2024,
making it the first drug to directly treat patients with the
common disorder that causes breathing disruption while
sleeping.