Adults With Overweight/Obesity and Type 2 Diabetes
Conditions
Brief 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
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.
Interventions
DRUGAT673 low dose
low dose
DRUGAT673 high dose
high dose
DRUGPlacebo
matching placebo
Sponsors
Antag Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 label. a) Note: Participants treated with sulfonylureas and/or DPP4 inhibitors must discontinue these at least 24 hours prior to initiation of semaglutide. 7. Participant has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator. 8. 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 9. Participants must, in the opinion of the Investigator, be suitable candidates to receive semaglutide (Wegovy®) as indicated according to the product label.
Exclusion criteria
1. 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: 1. Liposuction and/or abdominoplasty that was performed \> 1 year before screening 2. Laparoscopic gastric band that was removed \> 1 year before screening 3. Intragastric balloon that was removed \> 1 year before screening 4. Duodenal-jejunal bypass sleeve that was removed \> 1 year before screening. 2. 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. 3. Participant is currently using insulin or used insulin within 3 months before screening. 4. 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. 5. Participant has a form of diabetes other than type 2. a. Note: Previous diagnosis of gestational diabetes is permitted so long as the participant meets all inclusion and none of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 13 weeks | Percent change in body weight from baseline to week 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 13 weeks | Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol/mol) |
| Safety and Tolerability | 13 weeks | Frequency, severity and seriousness of treatment emergent AEs |
| Achieving clinically significant body weight loss from baseline to week 13 | week 13 | Proportion of participants achieving \>5%, and \>10% body weight loss from baseline to week 13 |
| Assess treatment effect on Body Mass Index | 13 weeks | — |
| Assess the treatment effect on insulin | 13 weeks | — |
| Assess the treatment effect on blood pressure | 13 weeks | — |
| Assess the treatment effect on markers of inflammation (hsCRP) | 13 weeks | — |
| Assess the treatment effect on lipid parameters | 13 weeks | — |
| Assess treatment effect on waist circumference | 13 weeks | — |
| Assess the treatment effect on fasting plasma glucose | 13 weeks | — |
| Assess the treatment effect on HOMA-IR | 13 weeks | — |
| Assess the treatment effect on heart rate | 13 weeks | — |
Countries
United States
Outcome results
None listed