The relative change in body weight at 48 weeks compared to baseline is the primary endpoint of the study.
Altimmune has completed dosing the last subject in its Phase II MOMENTUM clinical trial of pemvidutide to treat obesity or overweight.
The placebo-controlled, randomised, multi-centre study is being carried out at nearly 30 sites in the US.
The Center for Weight Management at Weill-Cornell Medical Center founder and director Dr Louis Aronne is the principal investigator of the study.
The trial will assess the safety and efficacy of the GLP-1/glucagon dual receptor agonist pemvidutide in subjects with obesity or overweight.
A total of 391 subjects will be randomised into a 1:1:1:1 ratio to receive either pemvidutide in 1.2mg, 1.8mg, 2.4mg, or placebo for 48 weeks. They will be given weekly dosages along with diet and exercise.
The relative (percent) change in body weight at 48 weeks compared to baseline is the primary endpoint of the study.
Additional readouts of the study include glucose homeostasis, cardiovascular measures, and metabolic and lipid profiles.
Altimmune president and CEO Vipin Garg said: “We remain on target to announce topline 48-week results from our Phase II MOMENTUM trial in the fourth quarter of this year.
“We believe pemvidutide offers a highly differentiated product profile that includes significant reductions in body weight, serum lipids and liver fat, without increases in heart rate or other cardiovascular safety signals.
“We also believe this combination of attributes has the potential to demonstrate best-in-class benefits in future cardiovascular outcome trials.”
Altimmune’s lead product candidate pemvidutide is also being developed for the treatment of non-alcoholic steatohepatitis.
The company is also developing HepTcell, an immunotherapeutic for a functional cure for chronic hepatitis B.