Altimmune has enrolled the first subject in the Phase II MOMENTUM clinical trial of its investigational therapy, pemvidutide, in participants with obesity or overweight.
A new peptide-based GLP-1/glucagon dual receptor agonist, pemvidutide is being developed to treat obesity and non-alcoholic steatohepatitis (NASH).
The randomised, placebo-controlled trial will analyse the safety and efficacy of pemvidutide versus placebo in nearly 320 non-diabetic individuals.
Being carried out in nearly 25 study centres in the US, the trial will randomise the subjects into a 1:1:1:1 ratio to receive either 1.2, 1.8, 2.4mg doses of pemvidutide or placebo every week for 48 weeks.
The relative variation from baseline in body weight at 48 weeks is the primary endpoint of the trial.
Further readouts such as metabolic and lipid profiles, cardiovascular measures and glucose homeostasis will also be analysed.
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The company intends to carry out an interim assessment to evaluate variations in body weight after 24 weeks and anticipates data readout in the fourth quarter of this year.
According to data from a Phase I trial, obese individuals had an average weight loss of 10.3% without diet or lifestyle modification following administration of subcutaneous doses of pemvidutide for 12 weeks.
Altimmune chief medical officer Dr Scott Harris said: “Initiation of the Phase II MOMENTUM obesity trial marks an important milestone in the development of pemvidutide.
“Built on a foundation of compelling Phase I clinical data, we see a great potential for pemvidutide to address the serious and widespread disease of obesity and its debilitating consequences.”
Meanwhile, the company concluded subject enrolment in the 12-week Phase Ib trial of pemvidutide in non-alcoholic fatty liver disease (NAFLD) patients.
In May last year, Altimmune reported preclinical data, where its single-dose intranasal Covid-19 vaccine, AdCOVID, showed positive results, with no detectable levels of virus in the lungs of vaccinated mice after challenge with the SARS-CoV-2 virus.