Antag Therapeutics
The goal of this clinical trial is to learn if AT673 contributes to additional weight loss and glycemic control when given with semaglutide in participants with overweight/obesity and type 2 diabetes. The main questions it aims to answer are: * To compare the effect on body weight of two doses of AT673 once-weekly versus matched placebo when concurrently administered with semaglutide once-weekly * To evaluate the effect of AT673 on glycated hemoglobin (HbA1c) * To compare the safety and tolerability of AT673 versus matched placebo when concurrently administered with semaglutide
This is a phase 2, double-blind, placebo-controlled study. Following screening, at their baseline visit, participants will initiate treatment with semaglutide at 0.25 mg/week and follow the product labelled dose escalation schedule until reaching the dose of 1.0 mg/week. Participants will remain on this dose until the end of study (EOS) visit. At the baseline visit, participants will be randomized in a 1:1:1 ratio to receive AT673 25 mg, or 50 mg, or matching placebo, respectively, once weekly at the same time as semaglutide. Participants will receive AT673 / placebo injections concurrently…
Inclusion Criteria: 1. Signed informed consent prior to start the Screening Visit procedures. 2. Female and male participants ≥18 years of age at time of consent 3. BMI g ≥27.0 kg/m2 at screening. 4. HbA1c ≥7 and ≤10% (53-86 mmol/mol) at screening. 5. Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening. 6. Either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, sulfonylurea, and/or DPP4 inhibitor as monotherapy or combination therapy, per approved local labe…
low dose
high dose
matching placebo