ABBV-295 for Obesity

Overseen ByABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Obesity medications

Disqualifiers: Recent weight change, High HbA1c, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ABBV-295, an experimental drug, to assess its impact on body weight and safety for individuals with obesity. Participants will receive either ABBV-295 or a placebo (a substance with no active drug) through injections over 13 weeks. The trial aims to identify any side effects and understand how the body processes the treatment. It suits adults with a consistent body mass index (BMI) between 30 and 45 who haven't experienced significant weight changes recently. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medication specifically for obesity, you must stop it at least 180 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ABBV-295, a long-acting hormone, is generally well-tolerated. Most side effects are mild and involve the stomach, such as nausea or an upset stomach. These effects resemble those observed in earlier studies with different doses.

Although this is an early-phase study, current data suggests the treatment's safety is promising. The primary goal of these trials is to closely examine safety and how the body processes the treatment. Participants in this study will help researchers gain a deeper understanding.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Most treatments for obesity focus on lifestyle changes, medications like orlistat, or even surgical procedures. But ABBV-295 works differently, potentially targeting specific biochemical pathways related to metabolism that current treatments don't directly address. Researchers are excited because ABBV-295 is administered via subcutaneous injection, which could offer a new way to deliver treatment with potentially faster or more targeted effects. This novel approach could provide another option for patients who haven't had success with existing therapies.

What evidence suggests that ABBV-295 might be an effective treatment for obesity?

Research has shown that ABBV-295 is being developed as a long-acting version of a hormone that aids in weight loss. Early results from similar treatments have demonstrated significant weight loss, ranging from 9.5% to 20.1% over 48 weeks, compared to just 0.4% with a placebo. Initial studies found that ABBV-295 is generally well tolerated, with mostly mild stomach-related side effects. While detailed results for ABBV-295 are still being gathered, its method of action and early data suggest it could effectively treat obesity. Participants in this trial will receive either ABBV-295 or a placebo to further evaluate its effectiveness and safety.¹ ² ⁶ ⁷ ⁸

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with obesity who are interested in participating in a study to evaluate the effects of ABBV-295. Specific eligibility criteria details are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

My BMI is between 30.0 and 45.0, including if I have stable conditions like high blood pressure.

I am not pregnant, breastfeeding, planning to become pregnant, or donate eggs soon.

Exclusion Criteria

I have lost or gained 5% or more of my body weight in the last 3 months.

HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening

Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 180 days prior to study treatment administration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

ABBV-295

Trial Overview

The study is testing ABBV-295 subcutaneous injections compared to a placebo. It aims to observe any adverse events, changes in body weight, and how the drug moves through and is processed by the body (pharmacokinetics).