Phase 2 Obesity Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give informed consent, are willing to follow all study procedures, and are available for the full duration of the trial.
• People with a body mass index (BMI) of 30 or higher, OR a BMI of 27 or higher alongside at least one weight-related health condition such as high blood pressure, heart disease, high cholesterol, or sleep apnea (whether treated or untreated).
• People who have smoked at least 5 cigarettes per day for at least one year before screening, and whose cotinine test (a test that confirms recent tobacco use) comes back positive.
• People who want to quit smoking and plan to do so within the next month.
• Women who could become pregnant must agree to use effective contraception during the trial, unless their male partner has had a vasectomy.
• Women who could become pregnant must have a negative urine pregnancy test before being assigned to a study group.
• People with a normal level of conscious control over their eating habits, as measured by a specific questionnaire score (confirm with trial site).
• People whose medical history and a brief physical check-up show no significant reasons that would make participation unsafe, in the judgment of the study doctors.

Who may not be able to join:

• People who personally have, or have a close blood relative with, a history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related hormone gland condition (multiple endocrine neoplasia type 2).
• People who have had acute pancreatitis (sudden inflammation of the pancreas) in the past 6 months.
• People with a history of or current chronic pancreatitis (long-term inflammation of the pancreas).
• People who have been diagnosed with type 1 or type 2 diabetes, or whose blood sugar screening results indicate diabetes.
• People with severe kidney disease or kidney failure, as shown by a blood test result below a certain threshold.
• People who have had a heart attack, stroke, hospitalisation for severe chest pain, or a mini-stroke within the past 60 days.
• People with significantly elevated blood pressure readings above a certain level (confirm with trial site for exact numbers).
• People who have had a cancer diagnosis in the past 5 years (certain minor skin cancers and non-invasive cancers may be acceptable — confirm with trial site).
• People with a serious digestive system condition, such as severe gastroparesis (a condition where the stomach empties too slowly).
• People with a known allergy or sensitivity to nicotine or nicotine patches, or to the study medication (semaglutide) or related products.
• Women who are currently pregnant, planning to become pregnant, or breastfeeding, or who could become pregnant and are not using an accepted form of contraception.
• People with any illness or condition that the study doctors believe would make it unsafe or not possible to complete the study.
• People who have used or been dependent on substances (other than nicotine) such as drugs or alcohol in the past 3 months.
• People whose urine drug test before the study starts is positive for substances including benzodiazepines, cocaine, opioids, amphetamines, methamphetamine, buprenorphine, barbiturates, MDMA (ecstasy), or THC (cannabis).
• People with a diagnosis of a psychotic disorder, bipolar disorder, a mood disorder with psychotic features, or an eating disorder.
• People assessed as having a moderate to high risk of suicidal thoughts or behaviour.
• People who have previously had bariatric (weight-loss) surgery.
• People who have gained or lost more than 4.5 kg in the 6 months before screening.
• People who are currently taking part in a structured weight management programme.
• People with an uncontrolled thyroid condition (assessed at the study doctors' discretion).
• People who currently use other tobacco products such as cigars, chewing tobacco, snuff, snus, or e-cigarettes.
• People currently using medications taken by mouth or injection to lower blood sugar.
• People currently using prescription or over-the-counter stop-smoking treatments such as nicotine replacement therapy, varenicline, or bupropion.
• People who are currently using, or have used in the past 90 days, any prescription medication for weight management.
• People who are currently using, or have used in the past 14 days, medications known to affect appetite or weight, such as corticosteroid tablets or injections (inhaled corticosteroids may be acceptable — confirm with trial site).
• People who are currently enrolled in, or expecting to join, another research study during this trial that could affect their safety or the study results.
• People who do not plan to remain living in the local area for the full duration of the trial.
• People who have a major surgery planned during the trial period (minor procedures may be acceptable — confirm with trial site).
• People who are not able to read, write, and speak English fluently.

Important: Always verify eligibility with the trial site directly before applying.