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Not yet recruiting NCT07654374

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

Phase III Interventional Obesity Overweight Chronic Weight Management Type2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: aleniglipron, aleniglipron, aleniglipron, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug aleniglipron
    Drug: aleniglipron administered orally
  • Drug aleniglipron
    Drug: aleniglipron administered orally
  • Drug aleniglipron
    Drug: aleniglipron administered orally
  • Drug Placebo
    Drug: placebo administered orally

Primary outcome measures

  • Percent change in body weight from Baseline [Time frame: Baseline and week 76]
Secondary outcome measures (9)
  • Change in body weight (absolute) from Baseline [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥5% reduction in body weight [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥10% reduction in body weight [Time frame: Baseline and week 76]
  • Percentage of participants who achieve ≥15% reduction in body weight [Time frame: Baseline and week 76]
  • Change in waist circumference from Baseline [Time frame: Baseline and week 76]
  • Change in HbA1c from Baseline [Time frame: Baseline and week 76]
  • Change in resting systolic blood pressure from Baseline [Time frame: Baseline and week 76]
  • Percent change in fasting triglycerides and non-HDL cholesterol from Baseline [Time frame: Baseline and week 76]
  • Percentage of participants achieving HbA1c target value of ≤6.5% [Time frame: Baseline and week 76]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 74 centers
  • ACCOMPLISH-2 Research Site — Birmingham
  • ACCOMPLISH-2 Research Site — Chandler
  • ACCOMPLISH-2 Research Site — Phoenix
  • ACCOMPLISH-2 Research Site — Sun City West
  • ACCOMPLISH-2 Research Site — Tucson
  • ACCOMPLISH-2 Research Site — Little Rock
  • ACCOMPLISH-2 Research Site — Escondido
  • ACCOMPLISH-2 Research Site — Fountain Valley
  • … and 66 more centers

Identifiers

NCT: NCT07654374 · GSBR-1290-15

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗