RightFit
RecruitingPhase 3

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

A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

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
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 how well different doses of aleniglipron work over time and how safe they are in adults with overweight or obesity and type 2 diabetes. Participants are assigned by chance to take aleniglipron or a placebo (a treatment with no active drug) for 76 weeks.

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.

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 27 or higher at screening. BMI is a measure of weight compared with height.
  • Have type 2 diabetes and an HbA1c from 6.5% to 10% at screening. HbA1c measures average blood sugar over the past few months.

Who can't join

  • Have any type of diabetes other than type 2, or have had ketoacidosis (dangerous acid buildup) or a hyperosmolar state or coma (dangerously high blood sugar).
  • Have had severe low blood sugar, or low blood sugar without noticing it, in the 180 days before screening.
  • Are getting or plan to get treatment for diabetic retinopathy (eye damage from diabetes) or macular edema (swelling in part of the eye).
  • Report gaining or losing more than 11 pounds (5 kg) in the 3 months before screening.
  • Have had or plan to have surgery or another treatment for obesity.

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

Official eligibility criteria

Inclusion Criteria: * 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 mmol/mol) at Screening Exclusion Criteria: * 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.

Study sites (74)

AL

AR

AZ

CA

CT

FL

GA

IA

ID

KS

MA

MD

MN

MO

MS

MT

  • ACCOMPLISH-2 Research Site · Missoula, MT 59804Medical Director GSBRClinicalTrials@structuretx.com · Study contactMore trials in Missoula

NC

NE

NV

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

WA