Trial studying safety and effects for Obesity
Official title Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
ClinicalTrials.gov ID: NCT07654361
What this study is testing
What is Aleniglipron?
Aleniglipron is an investigational medicine, given as an once-daily 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
- Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety.
- 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
You may be able to join if
- Signed informed consent
- BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
You likely can't join if
- Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
- Self-reported change in body weight \>5 kg within 3 months before Screening.
- Have prior or planned surgical or non-surgical treatment for obesity.
- Have or plan to have endoscopic and/or device-based therapy for obesity.
- Have obesity induced by other endocrine disorders.
- Impaired renal function at Screening
See the full eligibility criteria
- Signed informed consent
- BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
- Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
- Self-reported change in body weight \>5 kg within 3 months before Screening.
- Have prior or planned surgical or non-surgical treatment for obesity.
- Have or plan to have endoscopic and/or device-based therapy for obesity.
- Have obesity induced by other endocrine disorders.
- Impaired renal function at Screening
- Chronic malabsorption
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Sun City West, Arizona, United States
- Tucson, Arizona, United States
- Escondido, California, United States
- Gardena, California, United States
- La Jolla, California, United States
- Modesto, California, United States
- Rolling Hills Estates, California, United States
- San Diego, California, United States
- Clearwater, Florida, United States
- Leesburg, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Ocoee, Florida, United States
- Pembroke, Florida, United States
- Tampa, Florida, United States
- Buford, Georgia, United States
- Columbus, Georgia, United States
- Lawrenceville, Georgia, United States
+ 47 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Sun City West, Arizona, United States; Tucson, Arizona, United States; Escondido, California, United States; Gardena, California, United States and 61 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.