June 23 (Reuters) - People started on a low dose of
Amgen's ( AMGN ) long-acting experimental obesity drug MariTide lost as
much weight as those given high doses but with milder side
effects, according to full results of a mid-stage trial
presented at a medical meeting on Monday.
As a result, Amgen ( AMGN ) said its recently launched
72-week Phase 3 trial will randomize obese or overweight adults
to three different doses, with each group started at a much
lower dose that will be increased over an eight-week period.
"MariTide is a long-acting drug, but side effects are
short-lived, which is a great learning and gives us confidence
to go into Phase 3," Jay Bradner, executive vice president of
research and development at Amgen ( AMGN ), told Reuters.
The company previously announced top-line results from the
year-long Phase 2 trial showing that MariTide, injected monthly
or every other month, helped overweight or obese patients shed
up to 20% of their body weight.
The full results were presented at the American Diabetes
Association meeting in Chicago and published in the New England
Journal of Medicine.
The data show that for people with type 2 diabetes, MariTide
lowered blood sugar by up to 2.2 percentage points. Amgen ( AMGN ) said
weight loss with MariTide also improved pre-specified
cardiometabolic measures, including waist circumference, blood
pressure, inflammation markers and blood lipids.
MariTide is an antibody linked to a pair of peptides that
activates receptors for the appetite- and blood sugar-reducing
hormone GLP-1 while simultaneously blocking a second gut hormone
called GIP.
Amgen ( AMGN ) said no new safety signals were identified in the
study and tolerability was consistent with the GLP-1 class,
which is associated with gastrointestinal side effects such as
nausea.
In late-stage trials, Novo Nordisk's GLP-1
obesity drug Wegovy had a vomiting rate of 24%, while Eli
Lilly's ( LLY ) Zepbound, which is designed to activate both
GLP-1 and GIP, had a rate of 13%. Each of those drugs are given
as weekly injections.
In the mid-stage MariTide study, vomiting was reported by
nearly 90% of patients started at the highest tested dose,
compared with 50% of patients ramped up to a full dose in one
step and 22% of those brought to their target dose over eight
weeks.
Amgen ( AMGN ) said trial discontinuation rates due to
gastrointestinal issues of up to 7.8% were lower for groups
treated with escalating doses.
The company said it plans to start additional Phase 3
studies this year for MariTide in patients with a variety of
serious health issues, including cardiovascular disease caused
by clogging arteries, heart failure, and obstructive sleep
apnea.