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A Phase 2, Randomized, Double-blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed consent prior to start the Screening Visit procedures.

• Female and male participants ≥18 years of age at time of consent

• BMI g ≥27.0 kg/m2 at screening.

• HbA1c ≥7 and ≤10% (53-86 mmol/mol) at screening.

• Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.

• 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 label.

• a) Note: Participants treated with sulfonylureas and/or DPP4 inhibitors must discontinue these at least 24 hours prior to initiation of semaglutide.

• Participant has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.

• Women of childbearing potential (WOCBP) meeting the criteria below:

• i) Non-lactating and has a negative pregnancy test at screening and baseline -AND- ii) Uses an acceptable method of contraception as determined by the Investigator or Sub-Investigator for the duration of the study and 30 days following the last dose of study drug

• Participants must, in the opinion of the Investigator, be suitable candidates to receive semaglutide (Wegovy®) as indicated according to the product label.

Locations
United States
Arizona
CenExel Phoenix
RECRUITING
Chandler
California
CenExel Anaheim
RECRUITING
Anaheim
Florida
CenExel Hollywood
RECRUITING
Hollywood
CenExel Tampa
RECRUITING
Tampa
Georgia
CenExel Atlanta
RECRUITING
Atlanta
CenExel Decatur
RECRUITING
Decatur
CenExel Savannah
RECRUITING
Savannah
Utah
CenExel SLC
RECRUITING
Salt Lake City
Time Frame
Start Date: 2026-06-19
Estimated Completion Date: 2027-03
Participants
Target number of participants: 150
Treatments
Experimental: Low dose
Low dose AT673, subcutaneous injection administered weekly
Experimental: High dose
High dose AT673 subcutaneous injection administered weekly
Placebo_comparator: Placebo
matching placebo subcutaneous injection administered weekly
Related Therapeutic Areas
Sponsors
Leads: Antag Therapeutics

This content was sourced from clinicaltrials.gov