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

RecruitingPhase 3Ages 18 Years - 79 YearsAllGasherbrum Bio, Inc., a wholly owned subsidiary o…
NCT07654361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Aleniglipron
  • Placebo
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Where

71 sites
ACCOMPLISH-1 Research Site
Birmingham, United States
ACCOMPLISH-1 Research Site
Birmingham, United States
ACCOMPLISH-1 Research Site
Phoenix, United States
ACCOMPLISH-1 Research Site
Sun City West, United States
ACCOMPLISH-1 Research Site
Tucson, United States
ACCOMPLISH-1 Research Site
Escondido, United States
ACCOMPLISH-1 Research Site
Gardena, United States
ACCOMPLISH-1 Research Site
La Jolla, United States

…and 63 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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