[Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity
May 16 2024 - 1:00AM
UK Regulatory
[Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive
Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in
people with obesity
- Over 24 weeks, a
once-weekly subcutaneous injection of CT-388 achieved a clinically
meaningful and statistically significant mean placebo-adjusted
weight loss of 18.8% (p < 0.001)
- At week 24, 100% of CT-388
treated participants achieved >5% weight loss, 70% achieved
>15% and 45% achieved >20% weight loss
- In a subgroup with
pre-diabetes at baseline, CT-388 treatment normalised glycemia in
all patients, indicating its strong impact on glucose
homeostasis
- No new or unexpected safety
signals were detected. Overall, CT-388 demonstrated a safety and
tolerability profile consistent with its drug class
Basel, 16 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today positive results from the Phase I clinical trial of
CT-388, a dual GLP-1/GIP receptor agonist being developed for the
treatment of obesity and type 2 diabetes. The study found that a
once-weekly subcutaneous injection of CT-388 over 24 weeks resulted
in significant weight loss in healthy adults with obesity compared
to placebo. The weight loss achieved with CT-388 was clinically
meaningful, with a mean placebo-adjusted weight loss of 18.8%
(p-value < 0.001). At week 24, 100% of CT-388 treated
participants achieved a weight loss of >5%, 85% achieved
>10%, 70% achieved >15%, and 45% achieved >20%. The
treatment was well tolerated, with mild to moderate
gastrointestinal-related adverse events being the most common,
consistent with the incretin class of medicines that CT-388 belongs
to. All participants with a pre-diabetes status at baseline became
normoglycemic after 24 weeks of CT-388 treatment, whereas glycemic
status of participants treated with placebo remained largely
unchanged during this period.
“We are very pleased to see the significant and clinically
meaningful weight loss in people treated with CT-388,” said Levi
Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of
Global Product Development. “The results are highly encouraging for
further development of CT-388 for both obesity and type 2 diabetes
and underscore its potential to become a best-in-class therapy with
durable weight loss and glucose control.”
Obesity is one of the most urgent health challenges in the world
with extensive comorbidities, such as type 2 diabetes,
cardiovascular diseases, steatohepatitis and chronic kidney
disease. Over four billion people - about 50% of the world’s
population - are estimated to be impacted by obesity or being
overweight by 2035. The growing number puts an incredible strain on
societies and healthcare systems around the world.
CT-388 belongs to the class of incretin-based medicines that aim
to regulate blood sugar and reduce appetite. It selectively targets
and activates two specific receptors in the body, known as GLP-1
and GIP, which integrate nutrient-derived signals to control food
intake, energy absorption and assimilation. It is hypothesised that
the dual targeting effect of CT-388 could result in a meaningful
durable glucose reduction and weight loss, in addition to a
favourable safety profile.
An additional cohort from the ongoing placebo-controlled Phase I
trial of CT-388 will evaluate obese patients (BMI>30 kg/m2) with
type 2 diabetes over a 12-week treatment duration. Roche expects
data from this additional cohort in the second half of 2024.
About the CT-388 study
The CT-388-101 trial is a multi-arm, multi-cohort Phase I
randomised, double-blind, placebo-controlled study designed to
evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of CT-388 in otherwise-healthy adult participants
with overweight or obesity and in participants with obesity and
type-2 diabetes mellitus.
The primary endpoint of the trial is safety and tolerability of
CT-388; secondary endpoints include its effect on body weight and
glucose homeostasis. Pharmacokinetics and other pharmacodynamic
effects of CT-388 were also assessed.
About CT-388
CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP
receptor agonist being developed for the treatment of obesity and
type 2 diabetes (T2D). CT-388 was designed to have potent activity
on both the GLP-1 and GIP receptors but with minimal to no
ß-arrestin recruitment on either receptor. This biased signalling
significantly minimises receptor internalisation and consequent
desensitisation, which is expected to lead to prolonged
pharmacological activity. It is currently being studied in a
multi-part, multi-cohort Phase 1 clinical trial in people with
overweight/obesity with and without T2D.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
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