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
Stock Exchange Announcement no 32 / 2007