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 with Semaglutide during weekly clinic visits. Treatment with the AT673 / placebo will continue through the end of 13 weeks. This will be followed by a 4-week safety follow-up. The end of study visit will be at week 17.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
CenExel Phoenix
Chandler, Arizona, United States
RECRUITINGCenExel Anaheim
Anaheim, California, United States
RECRUITINGCenExel Hollywood
Hollywood, Florida, United States
RECRUITINGCenExel Tampa
Tampa, Florida, United States
RECRUITINGCenExel Atlanta
Atlanta, Georgia, United States
RECRUITINGCenExel Decatur
Decatur, Georgia, United States
RECRUITINGCenExel Savannah
Savannah, Georgia, United States
RECRUITINGCenExel SLC
Salt Lake City, Utah, United States
RECRUITINGBody weight
Percent change in body weight from baseline to week 13
Time frame: 13 weeks
HbA1c
Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol/mol)
Time frame: 13 weeks
Safety and Tolerability
Frequency, severity and seriousness of treatment emergent AEs
Time frame: 13 weeks
Achieving clinically significant body weight loss from baseline to week 13
Proportion of participants achieving \>5%, and \>10% body weight loss from baseline to week 13
Time frame: week 13
Assess treatment effect on Body Mass Index
Time frame: 13 weeks
Assess the treatment effect on insulin
Time frame: 13 weeks
Assess the treatment effect on blood pressure
Time frame: 13 weeks
Assess the treatment effect on markers of inflammation (hsCRP)
Time frame: 13 weeks
Assess the treatment effect on lipid parameters
Time frame: 13 weeks
Assess treatment effect on waist circumference
Time frame: 13 weeks
Assess the treatment effect on fasting plasma glucose
Time frame: 13 weeks
Assess the treatment effect on HOMA-IR
Time frame: 13 weeks
Assess the treatment effect on heart rate
Time frame: 13 weeks
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