Adults With Overweight/Obesity and Type 2 DiabetesPhase 2NCT07724340
A 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
A Phase 2 study testing AT673 low dose and AT673 high dose in people with Adults With Overweight/Obesity and Type 2 Diabetes, run by Antag Therapeutics at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults With Overweight/Obesity and Type 2 Diabetes
- What is being tested?
- AT673 low dose and AT673 high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Jun 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing, intragastric balloon, etc.) except for the following:
- Liposuction and/or abdominoplasty that was performed > 1 year before screening
- Laparoscopic gastric band that was removed > 1 year before screening
- Intragastric balloon that was removed > 1 year before screening
- Duodenal-jejunal bypass sleeve that was removed > 1 year before screening.
- Participant has had a self-reported or medically recorded change in body weight > 5% within 3 months of screening OR has recorded change in body weight >3% between screening and randomization.
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- Participant is currently using insulin or used insulin within 3 months before screening.
- Participant is currently using sulfonylureas and/or DPP4 inhibitors and is unable or unwilling to discontinue the use of these medications at least 24 hours prior to initiation of semaglutide.
- Participant has a form of diabetes other than type 2.
- Note: Previous diagnosis of gestational diabetes is permitted so long as the participant meets all inclusion and none of the exclusion criteria.
- Participant is currently using or used within 3 months before screening any weight reducing medication including pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion.
- Participant is currently using or used within 6 months before screening any medication that contains a GLP-1R agonist component or a GIPR modulator (either by prescription or as part of a clinical study)
- For participants with a history of prior GLP-1R agonist use (> 6 months prior to screening):
- Participant has had a previous intolerance or hypersensitivity to GLP-1 receptor agonists or any of its excipients.
- Participant has previously discontinued a GLP-1 receptor agonist after continuous treatment for 6 months or longer due to not meeting personal weight loss goals.
- Participant is taking any medication that, may cause weight gain unless the participant has used these medications for more than 6 months at a stable dose prior to screening.
- Participant has hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase levels >2.5, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening.
- Participant's current alcohol intake exceeds 14 units/week for men or 7 units/week for women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits).
- Participant has a recent history of illicit substance use (< 3 months) or in the opinion of the Investigator suspicion of current illicit substance use.
- Participant has uncontrolled hypertension at screening (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg).
- A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at screening, or history of long QT syndrome.
- Concurrent participation in another interventional study (e.g., of a drug, over the counter product, device) or within ≤90 days or 5 half-lives prior to Screening.
- Participant is unable to understand and communicate with the investigators; or to understand the protocol requirements, instructions, study-related restrictions, nature, scope, and possible consequences of the clinical study; or is unlikely to comply with the study requirements (e.g., uncooperative attitude and improbability of completing the clinical study).
- Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study, or employee of the sponsor, site, or Contract Research Organization (CRO).
- Participant whose obesity can be traced to a medical cause, suggestive of genetic or syndromic obesity of an endocrinologic disorder (e.g., hypothyroidism, Cushings syndrome, Prader-Willi syndrome).
- Participant has a history of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years, except for basal cell carcinoma.
- Participant has a glomerular filtration rate < 60 mL/min/1.73 m2.
- Participant has a history of major psychiatric disorders within 5 years or lifetime history of suicide attempt.
- Participant has any suicidal ideation of type 4 or 5 on the C-SSRS at screening.
- Participant with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia (MEN) syndrome type 2.
- Participant with a previous history of chronic pancreatitis, or acute pancreatitis within 6 months prior to screening.
- In the opinion of the Investigator, any disorder, condition, inability or unwillingness not covered by the exclusion criteria that may interfere with study procedures, assessments or participant's safety.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
CenExel Anaheim
Anaheim, California, 92801
CenExel Atlanta
Atlanta, Georgia, 30331
CenExel Phoenix
Chandler, Arizona, 85224
CenExel Decatur
Decatur, Georgia, 30030
CenExel Hollywood
Hollywood, Florida, 33024
CenExel SLC
Salt Lake City, Utah, 84107
CenExel Savannah
Savannah, Georgia, 31405
CenExel Tampa
Tampa, Florida, 33613
About this study
Official title: 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
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
Read the detailed description
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.
- Being tested
- AT673 low dose, AT673 high dose, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT673 low doseDrug
low dose
AT673 high doseDrug
high dose
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Low dose AT673, subcutaneous injection administered weekly Receives: Drug: AT673 low dose |
| High dose | Experimental | High dose AT673 subcutaneous injection administered weekly Receives: Drug: AT673 high dose |
| Placebo | Placebo comparator | matching placebo subcutaneous injection administered weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Percent change in body weight from baseline to week 13
Measured: 13 weeks
Secondary outcomes (12)
HbA1c
Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol/mol)
Measured: 13 weeks
Safety and Tolerability
Frequency, severity and seriousness of treatment emergent AEs
Measured: 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
Measured: week 13
Assess treatment effect on Body Mass Index
Measured: 13 weeks
Assess the treatment effect on insulin
Measured: 13 weeks
Assess the treatment effect on blood pressure
Measured: 13 weeks
Assess the treatment effect on markers of inflammation (hsCRP)
Measured: 13 weeks
Assess the treatment effect on lipid parameters
Measured: 13 weeks
Assess treatment effect on waist circumference
Measured: 13 weeks
Assess the treatment effect on fasting plasma glucose
Measured: 13 weeks
Assess the treatment effect on HOMA-IR
Measured: 13 weeks
Assess the treatment effect on heart rate
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start19 Jun 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Overweight/Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antag Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724340
- Sponsor's protocol ID
- AT673-OB-200
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07724340
- Acronym / sponsor ID
- AT673-OB-200
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Antag TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: AT673 low doseLow dose AT673, subcutaneous injection administered weekly |
| High dose | Experimental | Drug: AT673 high doseHigh dose AT673 subcutaneous injection administered weekly |
| Placebo | Placebo comparator | Drug: Placebomatching placebo subcutaneous injection administered weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (32 listed)
- Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing, intragastric balloon, etc.) except for the following:
- Participant has had a self-reported or medically recorded change in body weight > 5% within 3 months of screening OR has recorded change in body weight >3% between screening and randomization.
- Participant is currently using insulin or used insulin within 3 months before screening.
- Participant is currently using sulfonylureas and/or DPP4 inhibitors and is unable or unwilling to discontinue the use of these medications at least 24 hours prior to initiation of semaglutide.
- Participant has a form of diabetes other than type 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT673 low doselow dose | Drug | Low dose |
| AT673 high dosehigh dose | Drug | High dose |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Body weight
Time frame: 13 weeks
Percent change in body weight from baseline to week 13
12 secondary outcomes
HbA1c
Time frame: 13 weeks
Safety and Tolerability
Time frame: 13 weeks
Achieving clinically significant 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT673 low dose and AT673 high dose in people with Adults With Overweight/Obesity and Type 2 Diabetes, run by Antag Therapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.