Genentech Reports Positive Phase Ib Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People With Obesity
16 Mayo 2024 - 12:10AM
Business Wire
– 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 normalized 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 –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced positive results from the Phase Ib 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., 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 hypothesized that
the dual targeting effect of CT-388 could result in a meaningful
durable glucose reduction and weight loss, in addition to a
favorable safety profile.
An additional cohort from the ongoing placebo-controlled Phase
Ib 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 Ib
randomized, 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 signaling
significantly minimizes receptor internalization and consequent
desensitization, 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 Genentech
Founded more than 40 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious and
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240515237076/en/
Media Contact: Meghan Hindman, (650) 467-6800
Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, +41
61 687 5284