Health Trials

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

ConditionsObesityOverweightChronic Weight ManagementType2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-79
SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • aleniglipron

    Drug

    Drug: aleniglipron administered orally

  • aleniglipron

    Drug

    Drug: aleniglipron administered orally

  • aleniglipron

    Drug

    Drug: aleniglipron administered orally

  • Placebo

    Drug

    Drug: placebo administered orally

Treatment groups

1,100 Participants
are divided into 4 treatment groups
Group A: aleniglipron Arm 1Experimental treatment 1 intervention
Group B: aleniglipron Arm 2Experimental treatment 1 intervention
Group C: aleniglipron Arm 3Experimental treatment 1 intervention
Group D: Placebo Arm 4Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in body weight from Baseline

Time frame
Baseline and week 76

Secondary outcomes

1

Change in body weight (absolute) from Baseline

Time frame
Baseline and week 76
2

Percentage of participants who achieve ≥5% reduction in body weight

Time frame
Baseline and week 76
3

Percentage of participants who achieve ≥10% reduction in body weight

Time frame
Baseline and week 76
4

Percentage of participants who achieve ≥15% reduction in body weight

Time frame
Baseline and week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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