RightFit
RecruitingPhase 3

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests three once-daily doses of aleniglipron against a placebo (a pill with no active medicine) for at least 76 weeks. It will look at weight loss, safety, and side effects while people eat fewer calories and get more physical activity. It is for people with obesity, or people who are overweight and have at least one weight-related health problem.

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. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study after learning about it.
  • Have a BMI of 30 or higher, or a BMI of 27 or higher with at least one weight-related health problem. BMI is a measure of weight compared with height.

Who can't join

  • Have a past diagnosis of any type of diabetes.
  • Report a weight change of more than 5 kg (about 11 pounds) in the 3 months before screening.
  • Have had or plan to have surgery or other treatment for obesity.
  • Have or plan to have obesity treatment using a device or an endoscope (a tube used to look inside the body).
  • Have obesity caused by another hormone disorder.
  • Have kidneys that do not work well at screening.
  • Have a long-term problem absorbing nutrients from food.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * 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

Study sites (71)

AL

AZ

CA

FL

GA

HI

IA

ID

IL

KS

KY

LA

MA

MD

MI

MN

MO

MS

MT

NC

NE

NV

NY

OH

OK

OR

PA

SC

TN

TX

UT

WA