AbbVie experiences key knowledge from the Section I ABBV-295 research
AbbVie has reported constructive topline knowledge from the a number of ascending dose (MAD) portion of its Section I trial of ABBV-295 for weight reduction.
This research aimed to evaluate the tolerability, security, pharmacokinetics and pharmacodynamics of subcutaneous ABBV-295, a long-acting amylin analogue, in adults with a imply physique mass index (BMI) lower than 30 kg/m².
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The only-center, two-part, placebo-controlled, double-blind (inside cohorts), randomized research included each single and a number of ascending dose sections.
Within the MAD half, 76 individuals, largely males (88.3%), obtained doses starting from 2 mg to 14 mg and totally different titration schedules. The research assessed totally different dosing frequencies.
ABBV-295 was discovered to be usually properly tolerated in any respect dose ranges examined. The most typical unwanted side effects have been delicate gastrointestinal disturbances, which primarily occurred in the course of the first six weeks of therapy.
Examine outcomes demonstrated clinically significant, dose-dependent reductions in physique weight over the 12- to 13-week therapy interval, in comparison with baseline.
For these handled with ABBV-295, the least squares imply p.c change in physique weight ranged from -7.75% to -9.79% at week 12 for weekly dosing teams, and from -7.86% to -9.73% at week 13 for each different week and month-to-month dosing teams after week 5.
In distinction, individuals on placebo confirmed modifications of -0.26% and -0.25% at weeks 12 and 13, respectively.
AbbVie’s international improvement in immunology, neuroscience, eye care and specialty senior vice chairman Primal Kaur mentioned: “Weight problems is a fancy, persistent illness that imposes a big burden on sufferers, healthcare programs and society, and there stays a vital want for therapies that mix efficacy with tolerability and assist long-term adherence.
“We’re inspired by these preliminary outcomes for ABBV-295, which show significant weight reduction together with a well-tolerated security profile. These preliminary outcomes strengthen the potential of ABBV-295 as a novel therapeutic choice for individuals with weight problems.”
Examine knowledge from single ascending dose cohorts have been beforehand reported.
ABBV-295 targets amylin and calcitonin receptors to suppress urge for food and delay gastric emptying for potential therapy of weight problems. It has not obtained regulatory approval worldwide.
In December 2025, AbbVie reported main knowledge from the ECLIPSE Section III trial, which assessed the tolerability, security and efficacy of Aquipta (atogepant) 60 mg in comparison with placebo for the therapy of acute migraine in adults, each with and with out aura.
