Clinical trial for Obesity
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?
aleniglipron is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for obesity.
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
- This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.
- 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's taking place
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Sun City West, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Fountain Valley, California, United States
- La Jolla, California, United States
- Lake Forest, California, United States
- Rolling Hills Estates, California, United States
- San Diego, California, United States
- Tustin, California, United States
- Waterbury, Connecticut, United States
- Clearwater, Florida, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Leesburg, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
+ 51 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 - 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?
Study sites include Birmingham, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Sun City West, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States and 65 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.