New Phase 2 Study Shows That Liraglutide Leads to Significant Weight Loss in Obese People
COPENHAGEN, 20 Nov 2007 - Novo Nordisk today announced
clinical results from a double-blind, placebo-controlled phase 2
study comparing liraglutide, the once-daily human GLP-1 analogue,
with orlistat, a lipase inhibitor, for treatment of obesity in
people who do not have diabetes.
The study demonstrated that liraglutide given once daily over 20
weeks at the highest dose led to a weight loss from baseline of
just above 7 kg in comparison to a weight loss of just below 3 kg
in the placebo group and a weight loss of just above 4 kg in the
orlistat-treated group. All doses of liraglutide reduced body
weight. More than 75% of the people treated with the highest dose
experienced a weight loss larger than 5%, and more than 25%
experienced a weight loss larger than 10% relative to their body
weight at randomisation. Finally, the study revealed a beneficial
effect on systolic blood pressure after treatment with
liraglutide.
Approximately 30% of the 564 participants in the study showed signs
of prediabetes at randomisation. Following 20 weeks of treatment
with any dose of liraglutide, between 80% and 90% of these
participants no longer showed any sign of prediabetes, as opposed
to around 40% in the placebo- and orlistat-treated groups.
Liraglutide was generally well tolerated. The overall withdrawal
rate across the study was around 20%, and no more than 10% of the
people who were treated with liraglutide withdrew from the trial
due to adverse events. Consistent with all previous trials, the
most common adverse events were related to the gastrointestinal
systems and mainly rated as mild to moderate. The most frequently
reported individual adverse event was nausea. The frequency of
events was dose dependent and in the range of 20% to 50%. Nausea
was most frequently observed at the beginning of the study.
In order to study the long-term weight reduction of liraglutide
treatment, around 85% of all participants in the study volunteered
to continue into an open label extension phase of the study.
Mads Krogsgaard Thomsen, chief science officer, said: "We are very
encouraged by these new results. They give us reason to believe
that liraglutide has the potential to become a new and important
treatment option in the fight against serious obesity."
The results of the phase 2 trial do not change Novo Nordisk's
expectations for the company's financial results for 2007, which
were provided on 31 October in connection with the release of the
financial results for the first nine months of 2007.
Conference call
At 15.00 CET today, corresponding to 9.00 am New York time, a
conference call for investors will be held. Investors will be able
to listen in via a link on novonordisk.com, which can be found
under 'Investors - Download centre'.
About the study design
After an initial run-in period of two weeks with dietary advice and
daily injections of placebo, study participants were randomised to
either placebo, to increasing doses of liraglutide or to an
open-labelled control arm with orlistat for a treatment period of
20 weeks. 564 people with an average baseline weight at
randomisation of just below 100 kg entered the study.
About prediabetes
People with prediabetes are characterised by having either levels
of fasting glucose (Impaired Fasting Glucose) or levels of glucose
in a glucose tolerance test (Impaired Glucose Tolerance) that are
too high to be considered normal, but not high enough to meet the
criteria for diagnosis of diabetes. People with prediabetes are at
a higher risk of developing both cardiovascular disease and actual
diabetes. Prediabetes is often associated with the so-called
metabolic syndrome which in addition to high blood glucose levels
includes obesity, abnormal blood lipid levels and elevated blood
pressure.
About treatment of obesity with liraglutide
Obesity is an increasing global problem, which is associated with
increased risk of developing type 2 diabetes and other serious
conditions. It is generally agreed that the best way to tackle
obesity is through exercise and healthy diets. It is, however, also
recognised that for some it is difficult to achieve and maintain
the needed weight reduction even with substantial efforts. Thus, in
people who are at high risk of getting obesity-related
complications, for example patients with additional risk factors
such as osteoarthritis, hypertension or cardiovascular disease,
adjunctive treatment with medicine may be needed to reduce the risk
of complications and improve quality of life.
About liraglutide
Liraglutide is Novo Nordisk's once-daily GLP-1 analogue, currently
in phase 3 development for treatment of type 2 diabetes and phase 2
development for treatment of obesity. Results from four of five
phase 3 studies in people with type 2 diabetes have been reported.
The last study will be reported on around the turn of the year, and
submission for regulatory approval for treatment of type 2 diabetes
is expected mid 2008.
Novo Nordisk is a healthcare company and a world leader in diabetes
care. The company has the broadest diabetes product portfolio in
the industry, including the most advanced products within the area
of insulin delivery systems. In addition, Novo Nordisk has a
leading position within areas such as haemostasis management,
growth hormone therapy and hormone replacement therapy. Novo
Nordisk manufactures and markets pharmaceutical products and
services that make a significant difference to patients, the
medical profession and society. With headquarters in Denmark, Novo
Nordisk employs approximately 25,800 employees in 79 countries, and
markets its products in 179 countries. Novo Nordisk's B shares are
listed on the stock exchanges in Copenhagen and London. Its ADRs
are listed on the New York Stock Exchange under the symbol 'NVO'.
For more information, visit novonordisk.com.
Further information:
Media: Investors:
Outside North America: Outside North America:
Elin K Hansen Mads Veggerby Lausten
Tel: (+45) 4442 3450 Tel: (+45) 4443 7919
ekh@novonordisk.com
mlau@novonordisk.com
Hans Rommer
Tel (direct): (+45) 4442 4765
hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel: (+1) 609 902 9164 Tel: (+1) 609 919 7937
secl@novonordisk.com
cqfr@novonordisk.com
Posted: November 2007
