BridgeMD
New treatment option for Overweight
Official title A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults
ClinicalTrials.gov ID: NCT07465965
What this study is testing
What is Semaglutide Nasal Spray?
Semaglutide Nasal Spray is an investigational medicine, being studied as a potential treatment for overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female participants aged ≥18 years and ≤ 65 years.
- Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).
- Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).
- Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree...
- Negative anti-HIV antibody test result at screening.
You likely can't join if
- Diagnosis of type 1, type 2, or other forms of diabetes mellitus.
- Prior diagnosis of obesity caused by monogenic mutations or other medical conditions, including but not limited to hypothalamic obesity, pituitary...
- Prior history of bariatric surgery (excluding participants who had liposuction, abdominoplasty, intragastric balloon removal, or duodenal-jejunal...
- Use of any of the following treatments within 3 months prior to screening:
- Approved or unapproved anti-obesity medications (e.g., liraglutide, semaglutide, benaglutide, tirzepatide, orlistat, phentermine/topiramate...
- Any glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 related multi-agonists (e.g., GLP-1/glucose-dependent insulinotropic polypeptide [GIP]...
See the full eligibility criteria
Who can join
- Male or female participants aged ≥18 years and ≤ 65 years.
- Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).
- Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).
- Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree to use effective contraceptive methods and refrain from donating sperm...
- Negative anti-HIV antibody test result at screening.
- Participants must fully understand the trial objectives, nature, procedures, and potential adverse reactions, voluntarily participate, be able to communicate well with the investigators, comply with all study...
What rules you out
- Diagnosis of type 1, type 2, or other forms of diabetes mellitus.
- Prior diagnosis of obesity caused by monogenic mutations or other medical conditions, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma...
- Prior history of bariatric surgery (excluding participants who had liposuction, abdominoplasty, intragastric balloon removal, or duodenal-jejunal bypass sleeve removal \>1 year prior), or plan to undergo bariatric...
- Use of any of the following treatments within 3 months prior to screening:
- Approved or unapproved anti-obesity medications (e.g., liraglutide, semaglutide, benaglutide, tirzepatide, orlistat, phentermine/topiramate, naltrexone/bupropion), or herbal supplements, health products, meal...
- Any glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 related multi-agonists (e.g., GLP-1/glucose-dependent insulinotropic polypeptide [GIP] dual agonists, GLP-1/glucagon [GCG] dual agonists, GLP-1/GIP/GCG triple...
- Any antidiabetic medications (e.g., odium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, metformin, alpha-glucosidase inhibitors, insulin);
- Any other treatments known to affect body weight (e.g., cause weight loss or weight gain), including:
- Systemic corticosteroid therapy (intravenous or oral) for \>1 week
- Tricyclic antidepressants (e.g., imipramine, amitriptyline, doxepin)
- Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine)
- Antipsychotics/antiepileptics (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine HCl, clozapine, olanzapine, valproate derivatives, lithium preparations, thioridazine)
- Antihistamines (e.g., cyproheptadine, ketotifen, astemizole).
- Any investigational drugs, vaccines, or medical devices.
- Laboratory abnormalities at screening meeting any of the following:
- Glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥7.0 mmol/L;
- Uncontrolled hypertension, systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg;
- Thyroid-stimulating hormone (TSH) \>4.2 or \<0.27 mIU/L;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 × upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN;
- Fasting triglycerides \>3.42 mmol/L;
- Serum amylase or lipase ≥1.5×ULN;
- Calcitonin \> ULN;
- Estimated glomerular filtration rate (eGFR) ≤80 mL/min/1.73 m²;
- Clinically significant ECG findings: HR \ 100 bpm, second- or third- degree atrioventricular (AV) block, long QT syndrome, QTcF \>450 ms (male) or \>470 ms (female), left bundle branch block (LBBB), complete right...
- History of acute or chronic pancreatitis, or symptomatic gallbladder disease (except cholecystectomy).
- Participants with clinically significant abnormalities during nasal examination (including external nose and nasal cavity inspection) as determined by the investigator at screening.
- Nasal or sinus surgery or nasal trauma within 3 months prior to screening, not fully healed.
- Presence of nasal mucosal erosion, septal ulceration/perforation, or other nasal conditions (e.g., acute or chronic sinusitis, drug-induced rhinitis, allergic rhinitis, nasal polyps) that may affect intranasal drug...
- Participants with extensive scars or large tattoos on the abdomen, thighs, or upper arms that may interfere with drug administration.
- History of thyroid disease or abnormal thyroid function requiring treatment, deemed clinically significant.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Any malignancy diagnosed within 5 years (except cured basal cell carcinoma, cervical carcinoma in situ, localized prostate cancer post-surgery, or ductal carcinoma in situ post-surgery).
- History of major cardiovascular or cerebrovascular events: a) MI, PCI/CABG, valvular surgery, clinically significant arrhythmias requiring treatment, unstable angina, TIA, stroke within 6 months prior to screening, b)...
- Clinically significant gastrointestinal (GI) diseases at screening or within the screening period: pyloric obstruction, ileus, delayed gastric emptying, inflammatory bowel disease (IBD), gastroparesis, gastroesophageal...
- Participants positive for hepatitis B surface antigen anti-hepatitis C virus antibody, or RPR at screening;
- Participants with upper respiratory tract infection occurring within 7 days before administration.
- Major depressive disorder or other severe psychiatric illness (e.g., schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar disorder, epilepsy-related psychosis, intellectual disability with psychiatric...
- Blood donation within 3 months or total blood loss ≥400 mL within 6 months (excluding menstruation) prior to screening; planned donation within 3 months post-study.
- History of vasovagal syncope or intolerance to venipuncture/IV cannulation.
- Participants with a history of hypersensitivity or known/suspected allergy to GLP-1 receptor agonists or any excipients in the study drug formulation.
- History of alcohol abuse within 1 year prior to screening through check-in, defined as an average consumption \>14 units/week (1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine); unwilling to abstain from alcohol...
- Smoking \>5 cigarettes/day within 3 months prior to screening, or unwilling to abstain during study.
- History of substance abuse (including non-medical use of narcotics or psychotropic substances) within 1 year prior to screening through check-in; Positive drug screening test for: morphine, methamphetamine ("ice")...
- Female Participants who are pregnant or breastfeeding, or with positive serum pregnancy test results at screening, or positive urine pregnancy test at check-in (Day -1);
- Any other condition deemed by the investigator to render the participant unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Secaucus, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Secaucus, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.