AbbVie's amylin drug ABBV-295 shows up to 9.8% weight loss in Phase 1 trial

AbbVie said on March 9, 2026 that ABBV-295, an experimental long-acting amylin analog, produced average weight loss of 7.75% to 9.79% after 12 weeks in the weekly-dosing groups of a Phase 1 trial that enrolled 76 adults ^[1]. The drug, which AbbVie licensed from the Danish company Gubra, is listed for a Phase 2 study starting in the third quarter of 2026 ^[1][2].

What the trial measured

The single-center, placebo-controlled study tested subcutaneous doses from 2 mg to 14 mg using different dose levels and dosing schedules ^[1]. Participants had a mean body mass index below 30 kg/m2, meaning the group as a whole was not in the obesity range, and 88.3% were male ^[1].

Weekly-dosing groups lost 7.75%, 8.70% and 9.79% at week 12 ^[1]. A group that moved to every-other-week dosing lost 7.76% at week 12 and 9.73% at week 13, while a group that dosed monthly after week 5 lost 6.74% at week 12 and 7.86% at week 13 ^[1]. Placebo groups lost 0.26% at week 12 and 0.25% at week 13 ^[1].

Results were reported as least-squares means from a statistical model. Participants who could not stay on their assigned dosing plan were withdrawn and contributed no further efficacy data, according to the company's description of the analysis ^[1].

Tolerability and how the drug works

No serious adverse events were reported ^[1]. The most common side effects were gastrointestinal disorders, which were mostly mild and occurred mainly during the first six weeks of treatment ^[1].

ABBV-295 is an agonist that activates amylin and calcitonin receptors ^[1]. Amylin is a satiety hormone that signals the brain to reduce appetite and food intake and also acts to delay stomach emptying ^[1]. AbbVie describes the drug as mechanistically distinct from incretin-based therapies such as GLP-1 and GIP receptor agonists, the class that includes semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) ^[1].

"Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie ^[1]. "We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile," she said ^[1].

Whether similar weight loss would occur in a larger group of adults with obesity has not been reported. ABBV-295 has not been approved by any regulatory authority, and the company says its safety and efficacy have not been established ^[1].

Why it matters for patients

ABBV-295 works through a receptor pathway other than the GLP-1 and GIP receptors targeted by the weight-loss medicines now on the market ^[1]. If it succeeds in later trials, that could eventually add a different option for people who do not tolerate or do not respond to incretin-based drugs. That is a possibility based on mechanism only; no head-to-head comparison with an approved medicine has been reported ^[1].

Dosing frequency is the other notable finding. In this trial, every-other-week and monthly dosing produced weight reductions in the same range as weekly dosing at week 13 ^[1]. If that holds in larger studies, less frequent injections could matter for people who find weekly shots inconvenient. It has not been confirmed outside this small Phase 1 study.

This is early-stage data from a single trial, and it does not change any currently approved treatment option ^[1].

What happens next

A Phase 2 dose-finding study is listed with a start date of Aug. 3, 2026. It plans to enroll about 360 adults with obesity or overweight with weight-related conditions at roughly 70 sites in the United States and Puerto Rico, with 52 weeks of double-blind treatment and body weight at week 32 as the main goal ^[2]. Gubra said in a May 2026 trading statement that it expected AbbVie to begin Phase 2 in the third quarter of 2026 and to continue an ongoing Phase 1b study in patients with obesity ^[2].

A separate Phase 1 study of ABBV-295 in healthy Japanese adults with overweight or obesity is listed with a March 30, 2026 start date, and a drug-interaction study testing ABBV-295 with an oral contraceptive has been completed ^[2].

Full results from the Phase 1 multiple-ascending-dose study will be presented at a future scientific conference, according to AbbVie; no date has been disclosed ^[1].