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OverweightPhase 1NCT07465965

A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults

A Phase 1 study testing Semaglutide Nasal Spray and Semaglutide Injection in people with Overweight and Obesity, run by Shanghai World Leader Pharmaceutical Co., Ltd. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Semaglutide Nasal Spray and Semaglutide Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
2 Mar 2026to 30 Aug 2026
Phase
Phase 1
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 or eggs during this period.
  • 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 requirements, and sign the informed consent form before any study procedures begin.

Who cannot join

  • 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, acromegaly, or hypogonadism.
  • 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 surgery or use weight-loss devices during the study.
  • 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 replacements, or weight-loss capsules that may affect body weight;
  • 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 agonists), or combination preparations containing GLP-1 receptor agonists;
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  • 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 <40 or >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 bundle branch block (RBBB), Wolff-Parkinson-White (WPW) syndrome, or other clinically significant arrhythmias (e.g., paroxysmal supraventricular tachycardia (SVT), atrial flutter/fibrillation, ventricular flutter or fibrillation, sick sinus syndrome) deemed unsuitable by the investigator.
  • 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 deposition, as determined by the investigator.
  • 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) NYHA Class III-IV heart failure.
  • Clinically significant gastrointestinal (GI) diseases at screening or within the screening period: pyloric obstruction, ileus, delayed gastric emptying, inflammatory bowel disease (IBD), gastroparesis, gastroesophageal reflux disease (GERD), active peptic ulcer.
  • 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 symptoms) within 2 years before screening, or any history of self-harm or suicidal behavior, or participants with any suicidal ideation of type 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or type 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS.
  • 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 use during study, or a positive breath alcohol test (>0.0 mg/100 mL).
  • 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"), 3,4-methylenedioxymethamphetamine (MDMA, "ecstasy"), tetrahydrocannabinol (THC, cannabis), etc.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Frontage Clinical Services, Inc.

    Secaucus, New Jersey, 07094

    12014167766

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic (PK) of Single-dose Administration of Semaglutide Nasal Spray (WL1006) in Adult Overweight or Obese Participants

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.

Conditions
Overweight, Obesity
Being tested
Semaglutide Nasal Spray, Placebo, Semaglutide Injection
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Nasal SprayDrug

    WL1006

  • PlaceboDrug

    WL1006

  • Semaglutide InjectionDrug

    Wegovy®

Study groups in NCT07465965
Study groupRoleWhat they receive
Cohort A0 : Semaglutide Nasal SprayExperimentalNot described
Receives: Drug: Semaglutide Nasal Spray
Cohort A1: Semaglutide nasal spray and placeboExperimentalNot described
Receives: Drug: Semaglutide Nasal Spray; Drug: Placebo
Cohort A2:Semaglutide nasal spray and placeboExperimentalNot described
Receives: Drug: Semaglutide Nasal Spray; Drug: Placebo
Cohort A3: Semaglutide injectionActive comparatorNot described
Receives: Drug: Semaglutide Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax)

    Measured: Day 1 to Day 36 after administration

  2. Time to maximum concentration(Tmax)

    Measured: Day 1 to Day 36 after administration

  3. Area under the concentration-time curve from time 0 to time t (AUC0-t)

    Measured: Day 1 to Day 36 after administration

  4. Area under the concentration-time curve from time 0 to infinity(AUC0-∞)

    Measured: Day 1 to Day 36 after administration

  5. Percentage of AUC extrapolated(AUC%Extrap)

    Measured: Day 1 to Day 36 after administration

  6. Elimination half-life / Terminal half-life(t1/2)

    Measured: Day 1 to Day 36 after administration

  7. Apparent volume of distribution during terminal phase, adjusted for bioavailability (Vz/F)

    Measured: Day 1 to Day 36 after administration

  8. Apparent clearance, adjusted for bioavailability(CL/F)

    Measured: Day 1 to Day 36 after administration

  9. Terminal elimination rate constant(λz)

    Measured: Day 1 to Day 36 after administration

  10. Absolute bioavailability(F)

    Measured: Day 1 to Day 36 after administration

  11. Incidence and severity of treatment emergent adverse events (TEAEs)

    Measured: Day 1 to Day 36 after administration

  12. 12-Lead-ECGs(Electrocardiograms )

    Measured: Day 1 to Day 36 after administration

  13. Temperature

    Measured: Day 1 to Day 36 after administration

  14. Pulse

    Measured: Day 1 to Day 36 after administration

  15. Respiratory rate

    Measured: Day 1 to Day 36 after administration

  16. Blood pressure

    Measured: Day 1 to Day 36 after administration

  17. Urinalysis

    Measured: Day 1 to Day 36 after administration

  18. Blood biochemistry

    Alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, γ-glutamyl transferase, alkaline phosphatase, total protein, albumin, urea, uric acid, creatinine, calcium, chloride, potassium, sodium, phosphorus, total cholesterol, triglycerides, fasting blood glucose, creatine kinase, lactate dehydrogenase, amylase, lipase.

    Measured: Day 1 to Day 36 after administration

  19. Thyroid function

    Thyroid-stimulating hormone, total tri-iodothyronine, total thyroxine, free tri-iodothyronine, free thyroxine

    Measured: Day 1 to Day 36 after administration

  20. Virology test

    Measured: Day 1 to Day 36 after administration

  21. Urine pregnancy test

    Measured: Day 1 to Day 36 after administration

  22. Physical examination, includes: head, ears, eyes, nose and throat, skin, lymph nodes, neck, chest, abdomen, heart, cardiovascular, musculoskeletal system/extremities, neurological system and body weight.

    Measured: Day 1 to Day 4 after administration

  23. Hemoglobin

    Measured: Day 1 to Day 36 after administration

  24. Hematocrit

    Measured: Day 1 to Day 36 after administration

  25. Red blood cell count

    Measured: Day 1 to day 36

  26. White blood cell count

    Measured: Day 1 to day36

  27. Platelet count

    Measured: Day 1 to day 36

  28. Neutrophil percentage

    Measured: day 1 to day 36

  29. Eosinophil percentage

    Measured: day 1 to day 36

  30. Basophil percentage

    Measured: day 1 to day 36

  31. Monocyte percentage

    Measured: day 1 to day 36

  32. Lymphocyte percentage

    Measured: day 1 to day 36

  33. Activated partial thromboplastin time

    Measured: Day 1 to day 36

  34. Prothrombin time

    Measured: day 1 to day 36

  35. Fibrinogen

    Measured: day 1 to day 36

  36. Thrombin time

    Measured: day 1 to day 36

Secondary outcomes (4)
  1. Positive rate of Anti-Drug Antibody (ADA)

    Measured: Day 1 to Day 29 after administration

  2. Titer of Anti-Drug Antibody (ADA)

    Measured: Day 1 to Day 29 after administration

  3. Positive rate of Neutralizing antibody (Nab)

    if ADA is positive

    Measured: Day 1 to Day 29 after administration

  4. Titer of Neutralizing antibody (Nab)

    if ADA is positive

    Measured: Day 1 to Day 29 after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start2 Mar 2026
  3. Primary completion21 Aug 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465965
Sponsor's protocol ID
WL1006-US-I-01
Status last verified
Mar 2026
First submitted
28 Jan 2026
Last updated
12 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Semaglutide Nasal Spray and Semaglutide Injection in people with Overweight and Obesity, run by Shanghai World Leader Pharmaceutical Co., Ltd. at 1 site 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 6 inclusion and 45 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Guiyi Huang, Master (0086-18640027113, huangguiyi@worldleadertdds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) (time frame: Day 1 to Day 36 after administration). The study lists 36 primary outcomes in all. 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 12 Mar 2026.

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