1100 Participants NeededMy employer runs this trial

Aleniglipron for Diabetes and Obesity

Recruiting at 69 trial locations
MD
Overseen ByMedical Director
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called aleniglipron to determine its effectiveness for people with type 2 diabetes who are overweight or obese. Researchers aim to assess the long-term safety and efficacy of aleniglipron. Participants will receive either aleniglipron or a placebo (a harmless pill with no active ingredient) for about 76 weeks, assigned randomly. The trial seeks individuals diagnosed with type 2 diabetes and a BMI of 27 or higher. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that aleniglipron is likely to be safe for humans?

Research has shown that aleniglipron is generally safe, based on data from over 625 participants in various studies. Notably, no cases of liver damage linked to the drug were reported. Approximately 10.4% of participants discontinued the treatment due to side effects, indicating that most people tolerated aleniglipron well. These findings suggest the treatment is generally safe and well-tolerated, with side effects similar to other drugs in its group, known as GLP-1 receptor agonists.12345

Why do researchers think this study treatment might be promising?

Aleniglipron is unique because it targets both diabetes and obesity with a fresh approach. Unlike most diabetes treatments that focus on insulin regulation or glucose absorption, aleniglipron may work through a new mechanism that directly impacts metabolic processes linked to both conditions. This could mean better overall management of blood sugar levels and weight, potentially simplifying treatment for patients dealing with both issues simultaneously. Researchers are excited because this dual-action approach might offer a more comprehensive solution than the current standard therapies, like metformin or GLP-1 receptor agonists, which typically address one condition primarily.

What evidence suggests that aleniglipron might be an effective treatment for diabetes and obesity?

Research has shown that aleniglipron yields promising results for people with type 2 diabetes and obesity. In earlier studies, participants lost a significant amount of weight. For example, one study found an average weight loss of 16.3% (about 39 pounds), which exceeded the weight loss of those who took a placebo. Other studies reported weight loss between 11.3% and 14.7%. This treatment helps control blood sugar and reduce appetite, leading to weight loss. These findings highlight its potential as an effective treatment for managing weight in people with diabetes and obesity. Participants in this trial will receive aleniglipron or a placebo to further evaluate its effectiveness.12367

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity (BMI of 27 or higher) and have type 2 diabetes with moderately high blood sugar. People can't join if their weight changed a lot recently, they had severe low blood sugar episodes, eye treatments for diabetes, other types of diabetes, or past/planned weight loss surgery.

Inclusion Criteria

Have a BMI ≥27.0 kg/m2 at Screening
Signed Informed Consent
I have type 2 diabetes with an HbA1c between 6.5% and 10%.

Exclusion Criteria

Self-reported change in body weight >5 kg (11 pounds) within 3 months before Screening
I have had severe low blood sugar or didn't notice low blood sugar in the past 6 months.
I am currently being treated or planning treatment for diabetic eye disease or macular swelling.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either aleniglipron or placebo for chronic weight management

76 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • aleniglipron

Trial Overview

The study tests aleniglipron versus a placebo in adults with overweight/obesity and type 2 diabetes. Participants are randomly assigned to either the drug or placebo group without knowing which one they're getting. Treatment lasts about 76 weeks.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: aleniglipron Arm 3Experimental Treatment1 Intervention
Group II: aleniglipron Arm 2Experimental Treatment1 Intervention
Group III: aleniglipron Arm 1Experimental Treatment1 Intervention
Group IV: Placebo Arm 4Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
5
Recruited
530+

Citations

Oral small molecule GLP-1 receptor agonist aleniglipron in ...

−12.4% body weight loss by 72 weeks ・ clinically meaningful reductions in the three aleniglipron arms, ranging from −28.8% to −46.4%, compared ...

Press Release

aleniglipron achieved clinically meaningful and statistically significant placebo-adjusted mean weight loss of 16.3% (39 lbs; p<0.0001) at the ...

NCT07400588 | Aleniglipron Phase 2 in Type 2 Diabetes ...

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus … endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and ...

Aleniglipron Shows Positive Phase 2 ACCESS II Results in ...

aleniglipron demonstrated a substantial and statistically significant placebo-adjusted mean weight reduction of 16.3% (39 lbs; P<0.001) at 180 ...

Aleniglipron's Phase 2b Data Redraws the Oral GLP-1 ...

Structure Therapeutics' aleniglipron hit 14.7% weight loss in Phase 2b, matching injectable benchmarks. Here's what the trial design signals ...

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus

The purpose of this study is to assess the safety and tolerability of aleniglipron at doses up to 240 mg once daily (QD) in participants ...

NCT07654361 | Efficacy and Safety of Aleniglipron in ...

study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo,