AbbVie Inc. has unveiled encouraging early-stage results for its investigational obesity therapy ABBV-295, with data showing participants lost up to 9.79% of their body weight over a 12-week period. The Phase 1 clinical trial, which involved 76 adult patients, reported no serious adverse events, indicating a potentially favorable safety profile for the novel compound.
The study tested multiple dosing regimens, including weekly, bi-weekly, and monthly schedules after an initial period. Weekly administration yielded average weight loss ranging from 7.75% to 9.79% by week 12, while less frequent dosing showed comparable efficacy of 7.86% to 9.73% at week 13. Participants receiving a placebo experienced minimal weight change. Primal Kaur, AbbVie's Senior Vice President of Global Development, stated the results demonstrate "meaningful weight loss together with a well-tolerated safety profile."
This development is strategically significant for AbbVie as it actively diversifies its portfolio amid biosimilar competition for its flagship drug Humira. The company is investing heavily to expand into new therapeutic areas, including a recent $380 million commitment to boost manufacturing capacity in Illinois for obesity and neuroscience medicines. AbbVie has identified the obesity market as a major opportunity, projecting it could reach approximately $150 billion annually over the next decade.
ABBV-295 is an amylin-based medicine, a class of drugs that mimic a hormone produced by the pancreas to suppress appetite and slow gastric emptying. AbbVie's Chief Medical Officer, Roopal Thakkar, has emphasized that the focus for their obesity pipeline is on "tolerability and durability of weight loss," suggesting amylin agonists could offer advantages over popular GLP-1 receptor agonists like Novo Nordisk's Wegovy and Eli Lilly's Zepbound.
The company in-licensed the drug candidate from Danish biotech firm Gubra in March 2025, in a deal worth $350 million upfront and up to $1.875 billion in potential milestone payments. This agreement marked AbbVie's formal entry into the competitive obesity drug arena.
Analysts note that direct comparisons with rival programs are challenging due to differences in trial design, duration, and patient demographics. For context, Eli Lilly recently reported its mid-stage amylin drug, eloralintide, helped patients lose up to 20.1% of their weight after 48 weeks. Similarly, Roche and Zealand Pharma's petrelintide showed up to 10.7% weight loss over 42 weeks. AbbVie's Phase 1 trial had a predominantly male participant pool (88.3%) with a mean body mass index below 30.
Morningstar analyst Karen Andersen cautioned that cross-trial comparisons are difficult when patient populations vary, noting that women have historically shown better responses to weight-loss therapies than men. It is important to stress that Phase 1 trials are primarily designed to assess safety and tolerability, not definitive efficacy in broader patient groups. ABBV-295 is not approved for use anywhere and remains in early-stage testing.
Full data from the study are slated for presentation at a future scientific conference. AbbVie's shares showed little movement following the announcement, trading around $226.81 in afternoon U.S. trading on Tuesday, March 10, 2026. The readout provides an early signal that AbbVie could eventually become a contender in a market currently dominated by Eli Lilly and Novo Nordisk, as it seeks to bolster its long-term growth trajectory beyond its core immunology business.
