ABBV 295 shows extended half life and weight loss in Phase I obesity study

AbbVie has reported detailed Phase I data for ABBV 295, an investigational long acting amylin analogue being developed for chronic weight management.

The findings were presented at the 2026 European Association for the Study of Diabetes Annual Meeting and showed a pharmacokinetic profile that could support dosing less frequently than once a week.

ABBV 295 demonstrated a mean half life ranging from 10.7 to 12.3 days across the evaluated cohorts.

AbbVie said this supported the once weekly, every other week and monthly dosing regimens assessed in the study and could allow future development of dosing schedules extending beyond weekly administration.

The results come from the multiple ascending dose portion of the Phase I programme.

A total of 60 participants were included in Parts 2B and 2C, with 45 receiving ABBV 295 and 15 receiving placebo.

Participants had a mean age of 41.5 years and a mean body mass index of 29.3 kg per square metre, while 88% were male.

ABBV 295 was escalated to doses of 4 mg, 6 mg or 14 mg once weekly, 14 mg every other week, or 8 mg once monthly.

Treatment was administered for either 12 or 13 weeks.

Plasma exposure increased proportionally with dose.

Median time to maximum plasma concentration ranged from 24.0 to 48.1 hours.

The pharmacokinetic profile was accompanied by reductions in body weight across all active dosing schedules.

At week 12, least squares mean body weight reductions ranged from 7.8% to 9.8% across the once weekly cohorts.

Participants receiving 14 mg every other week achieved a mean reduction of 9.7% at week 13.

The monthly 8 mg group recorded a 7.9% reduction over the same period.

By comparison, body weight declined by approximately 0.3% among participants receiving placebo.

Primal Kaur, MD, Senior Vice President of Global Development for Immunology, Neuroscience, Eye Care and Specialty at AbbVie, said the findings support the development of differentiated obesity treatments beyond current incretin based approaches.

She said the weight reductions and long half life observed with ABBV 295 strengthen the rationale for continued investigation of the amylin pathway.

ABBV 295 also demonstrated a generally favourable tolerability profile during the study.

Gastrointestinal adverse events were predominantly mild and occurred mainly during the first six weeks of treatment.

Among participants who experienced a gastrointestinal adverse event, 92% had mild events as their highest severity.

Nausea was reported in 33.3% of participants receiving ABBV 295 compared with 20.0% of those receiving placebo.

Diarrhoea occurred in 20.0% of the ABBV 295 group and was not reported in the placebo group.

No severe gastrointestinal adverse events were observed.

Discontinuations due to gastrointestinal events occurred in 4.4% of participants receiving ABBV 295 and none receiving placebo.

No serious treatment emergent adverse events were reported, while the most common adverse events occurring in more than 20% of participants included decreased appetite, fatigue, headache, nausea and diarrhoea.

Juan Pablo Frías, MD, Medical Director and Principal Investigator at the Los Angeles Institute for Metabolic Research, said treatment convenience and tolerability are important considerations for long term obesity management.

He said the combination of weight reduction and a pharmacokinetic profile compatible with extended dosing intervals supports further clinical development of ABBV 295.

AbbVie plans to advance the investigational therapy into Phase II development for chronic weight management.

ABBV 295 remains investigational and has not been approved by regulatory authorities.

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Related Topics and Keywords

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