164 Participants NeededMy employer runs this trial

ACCG-2671 for Obesity

Recruiting at 5 trial locations
SA
Overseen BySara Ahmed MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics
Must be taking: Injectable GLP-1RA

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called ACCG-2671, focusing on its safety and behavior in the body. Researchers will explore how the drug works in both healthy individuals and those with obesity, a condition where body weight significantly exceeds healthy levels. The study consists of different parts: some participants will receive varying doses of the drug or a placebo (a harmless pill with no active drug) to observe its effects, while others will have their reaction to the drug tested with and without food. Part 3 of this trial seeks participants living with obesity (BMI of 30 or higher) who are already on a stable injectable GLP-1RA treatment (a common medication for managing obesity and diabetes) without side effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that ACCG-2671 is likely to be safe for humans?

Research has shown that ACCG-2671 is likely safe. In earlier studies, participants generally tolerated the treatment well. No serious negative side effects were reported, and no side effects linked to the drug appeared during treatment. This suggests ACCG-2671 could be safe for humans, but further research is needed to confirm this.12345

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide, ACCG-2671 offers a new approach by being administered orally in ascending and escalating doses. Researchers are excited about ACCG-2671 because it's designed to target weight loss through a potentially novel mechanism not yet seen in current medications. Additionally, the trial explores the drug's effectiveness under different conditions, like fasting and fed states, which could provide insights into optimizing its use for better results. This could mean a more tailored and efficient treatment option for individuals struggling with obesity.

What evidence suggests that ACCG-2671 might be an effective treatment for obesity?

Research has shown that ACCG-2671 yields promising results in weight loss. In earlier studies, this treatment caused significant weight loss in obese rats. Specifically, a previous study with people demonstrated that participants lost up to 16.2% of their body weight over 72 weeks, with no slowdown in weight loss. This trial will evaluate ACCG-2671 in various contexts, including escalating doses for participants living with obesity. The treatment targets specific body parts to help control appetite and weight. These early findings suggest it might be an effective option for managing obesity.46789

Are You a Good Fit for This Trial?

This trial is for healthy adults and otherwise healthy adults with obesity. Participants should not have serious medical conditions or be taking medications that could affect the study results.

Inclusion Criteria

Body weight ≥50.0 kg at screening
Signed informed consent
I am between 25 and 75 years old and my BMI is 30 or higher.
See 2 more

Exclusion Criteria

For Parts 1, 2, and 3, any evidence of exclusion criteria at Screening or prior to first dose
For Parts 1 and 2, any clinically significant medical conditions
I have not used any medications, supplements, or vitamins recently, except those allowed by the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive ascending doses of ACCG-2671 or placebo to assess safety, tolerability, and PK profile

3-4 weeks
Multiple visits for dose administration and monitoring

Food Effect

Participants receive a single dose of ACCG-2671 under fasted and fed conditions to assess the effect of food on PK, safety, and tolerability

3 weeks
Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants with obesity receive escalating doses of ACCG-2671 or placebo for 84 days to assess safety, tolerability, and PK profiles

12 weeks
Regular visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ACCG-2671

Trial Overview

The study is testing a new oral drug called ACCG-2671 at different doses, compared to a placebo. It will also look at how eating food affects the way the body processes this drug.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2 (Food-effect)Experimental Treatment1 Intervention
Group II: Part 1 (SAD)Experimental Treatment1 Intervention
Group III: ACCG-2671 Part 3 (MAD)Experimental Treatment1 Intervention
Group IV: Placebo Part 1 (SAD)Placebo Group1 Intervention
Group V: Placebo Part 3 (MAD)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aconcagua Bio, Inc. a wholly owned subsidiary of Structure Therapeutics

Lead Sponsor

Citations

Press Release

Participants achieved up to 16.2% body weight loss at 72 weeks with no evidence of weight loss plateau, and fewer than 5% discontinued treatment ...

Structure Therapeutics Announces Initiation of Phase 1 ...

Preclinical data of ACCG-2671 show potent target engagement, robust weight loss as a monotherapy and further weight loss when used in ...

Structure Therapeutics Reports Fourth Quarter and Full ...

ACCG-2671 is being evaluated in an ongoing single ascending dose (SAD) study to measure safety, tolerability, pharmacokinetics, and food-effect ...

ACCG-2671 / Structure Therap, Schrodinger

'The preclinical data being presented at ADA include the robust weight-loss effects of ACCG-2671 alone and in combination with a GLP-1 receptor agonist ...

Structure Therapeutics Selects Lead Oral Amylin Receptor ...

As an oral small molecule, ACCG-2671 offers scalability and combinability, enhancing patient access to effective weight loss treatments. Stevens ...

Amylin and GLP-1 Program Updates

Chief Executive Officer ACCG-2671: Leading Oral Obesity Portfolio. Chronic Weight Management in Adults with Obesity or Overweight. Sample Size ...

NCT07815678 | First-in-human Study of the Safety, ...

This first-in-human study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of ACCG-2671.

Press Release - Structure Therapeutics

ACCG-2671 demonstrate potent target engagement, robust weight loss, favorable safety profile and PK properties supportive of once-daily dosing ...

Safety, Tolerability, and Pharmacokinetics Evaluation of ...

This study aims to evaluate the safety, tolerability, and effects on the body of ACCG-2671 in both healthy individuals and those who are obese,