Effect of a Low-carbohydrate Diet on Weight Loss in People Using the Injectable GLP-1 Agonist Semaglutide for Weight Loss

Inclusion Criteria

• •Aged 18-75 years, inclusive
• •Overweight or obese individuals with a BMI ≥26 kg/m²
• •Non-pregnant, non-lactating individuals who are not planning on becoming pregnant during the trial and are using an effective method of contraception, as outlined: (a) Complete abstinence from intercourse two weeks prior to administration of the study product, and throughout the clinical trial. Participants utilizing this method must agree to use 2 alternate methods of contraception (see d) if they should become sexually active and will be queried on whether they have been abstinent at each study visit. b) Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant; c) Sexual partner(s) is/are exclusively female; d) Use of two acceptable methods of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation, contraceptive pill, intrauterine device (IUD) or contraceptive implant. The Participant must be using these methods for at least 1 week prior to the screening visit and throughout their participation in the trial.
• •Started semaglutide injections for weight loss 14 to 35 days prior to screening, inclusive, are tolerating it and are willing to continue taking it
• •HbA1c ≤7.5%
• •Not taking any hypoglycemic agent, apart from a semaglutide
• •Systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg
• •Serum creatinine \<180 mmol/L (\<2.1 mg/dL)
• •Serum triglycerides \<9 mmol/L (\<800 mg/dL)
• •ALT or AST \<3 times the upper limit of normal
• +10 more criteria