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Also known as GUBamy
GUB014295 · 1 trial · 2 indications
To provide safety information for GUB014295 by assessing: incidence of AEs categorized in System Organ Class (SOC) according to MedDRA (and evaluating severity and duration for SOC). No formal hypothesis will be tested in the study. Descriptive summaries for all safety safety data for all placebo, each active treatment and all active will be provided (including changes from baseline)
To provide safety information for GUB014295 by assessing: Any changes from baseline for vital signs including: Blood pressure, Pulse/heart rate, oral temperature and respiratory frequency summarized as a ratio (baseline/end of trial). No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to end of trial) for all safety safety data for all placebo, each active treatment and all active will be provided.
To provide safety information for GUB014295 by assessing a wide range of laboratory parameters within hematology, coagulation, clinical chemistry, virology, urinalysis. No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to day end of trial)) for all safety safety data for all placebo, each active treatment and all active will be provided.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | placebo solution |
| GUB014295 | ACTIVE_COMPARATOR | GUB014295 solution 5 mg/mL |
| Name | Type | Description |
|---|---|---|
| GUB014295 | DRUG | GUB014295 is a long-acting amylin analogue in development, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study |
| GUB014295-PLACEBO | DRUG | GUB014295-PLACEBO is matching GUB014295 in appearance, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study |
Inclusion Criteria: * Males (Part 1 only) aged 18 to 55 years, and males and females (Part 2 only) aged 18 to 65 years inclusive at the time of signing informed consent * Must agree to adhere to the contraception requirements * Lean to overweight or obese but otherwise healthy males (Part 1 and 2) ...
GUB014295 is an investigational small molecule being developed by AbbVie Inc. for overweight. It is a Phase 1 asset in the metabolic therapeutic area and has been studied in a first-in-human trial in healthy volunteers and overweight participants. It is not yet approved for any use.
GUB014295 is being developed for overweight. The single clinical trial conducted to date enrolled healthy volunteers and overweight participants, so the program is still at an early stage of development and no approved use exists for this drug.
GUB014295 targets amylin, a hormone. Amylin is involved in metabolic regulation, and the drug is a small molecule designed to act on this hormone target. This mechanism distinguishes it from peptide-based amylin approaches, though its clinical profile is still being established in early testing.
AbbVie Inc. (ticker ABBV) is developing GUB014295. The company is the sponsor of the Phase 1 first-in-human study of the drug, which was conducted in the United Kingdom. AbbVie holds the program as part of its metabolic pipeline.
GUB014295 is in Phase 1. It is investigational and has not been approved by the FDA or any other regulator. One Phase 1 trial has been completed, and no active trials are currently listed for the program.
GUB014295 has been studied in one Phase 1 trial, NCT06144684, titled a two-part first-in-human study to assess safety, tolerability, pharmacokinetics and pharmacodynamics. It was a randomized, double-blind, placebo-controlled trial that enrolled 76 participants in the United Kingdom and is now completed.