Recruiting at 57 sites Phase 3 Obesity

Obesity study: Aleniglipron

Official title A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

ClinicalTrials.gov ID: NCT07654374

What this study is testing

What is aleniglipron?

This is an investigational oral medicine being studied as a potential treatment for obesity and type 2 diabetes.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to learn whether aleniglipron is effective, safe, and well‑tolerated over the long term in people with overweight/obesity and type 2 diabetes.
Who it's for
Adults who have overweight or obesity together with type 2 diabetes.
What's involved
Participants will be randomly assigned to take aleniglipron or a placebo for about 76 weeks and will attend study visits for medication dispensing and safety checks.
Time commitment
The trial lasts roughly 76 weeks and includes regular study visits throughout that period.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 79. Healthy volunteers may be eligible.

You may be able to join if

  • Signed Informed Consent
  • Have a BMI ≥27.0 kg/m2 at Screening
  • Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86...

You likely can't join if

  • Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening.
  • Have prior or planned surgical or non-surgical treatment for obesity.

The study team makes the final eligibility decision.

Where it is enrolling

  • Birmingham, Alabama, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Sun City West, Arizona, United States
  • Tucson, Arizona, United States
  • Fountain Valley, California, United States
  • La Jolla, California, United States
  • Rolling Hills Estates, California, United States
  • San Diego, California, United States
  • Waterbury, Connecticut, United States
  • Clearwater, Florida, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Leesburg, Florida, United States
  • Ocala, Florida, United States
  • Ocoee, Florida, United States
  • Atlanta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Union City, Georgia, United States
  • Woodstock, Georgia, United States

+ 36 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Birmingham, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Sun City West, Arizona, United States; Tucson, Arizona, United States; Fountain Valley, California, United States and 50 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.