Not yet recruiting

Phase 2b Randomized Study of Semaglutide Subcutaneous Depot for Weight Reduction in Adults with Obesity or Overweight

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves adults who are classified as having obesity or are overweight, a condition where excess body fat can affect health. The medication being tested is a long‑acting form of semaglutide that is given as a subcutaneous injection. The product is identified by the code name CAM2056 and is available in two strengths, 10 mg and 20 mg, which are injected under the skin.

The purpose of the study is to determine whether the 20 mg dose leads to greater weight loss compared with placebo. Participants receive the assigned injection once every few weeks for a period of about nine months, with clinic visits at regular intervals to record changes in body weight and other health measures. During the study, health professionals will monitor changes in HbA1c, fasting plasma glucose, waist circumference, blood pressure, cholesterol and triglycerides to assess overall safety and effectiveness.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and assignment
After joining the study you will be randomly placed into one of three groups: a group that receives semaglutide 5 mg, a group that receives semaglutide 20 mg, or a group that receives a matching placebo. the assignment is double‑blind, so neither you nor the study staff will know which group you are in.
Step 2
Baseline assessments
Before any medication is given, a series of measurements will be taken. these include body weight, waist circumference, blood pressure (both systolic and diastolic), fasting blood glucose, hemoglobin a1c, and a lipid profile (cholesterol and triglycerides). the results provide a starting point for later comparisons.
Step 3
Start of study medication
You will receive a subcutaneous injection of the study medication you have been assigned to. the active drug is a solution of semaglutide at a concentration of 10 mg/mL (delivered as a 5 mg dose) or 20 mg/mL (delivered as a 20 mg dose). the placebo is an injection that looks identical but contains no active substance.
The injection schedule follows the study protocol and will continue for a total of 36 weeks. the exact frequency (for example, weekly) will be explained by the study team and recorded in your study diary.
Step 4
Regular follow‑up visits
You will attend clinic visits at week 12, week 24, and week 36. at each visit the same set of measurements taken at baseline will be repeated: body weight, waist circumference, blood pressure, fasting plasma glucose, hemoglobin a1c, and lipid levels.
These visits also allow the study staff to check that the injections are being given correctly and to collect any information about side effects.
Step 5
Monitoring for side effects
Throughout the 36‑week period you will be asked to report any unwanted symptoms or health changes. these are recorded as treatment‑emergent adverse events and are reviewed at each follow‑up visit.
Step 6
Final assessment and end of treatment
At week 36 a final set of measurements is performed, identical to the baseline and follow‑up assessments. after this visit the study medication is discontinued and no further injections are given.
Step 7
Study completion
Once the final assessment is finished, the study is considered complete for you. any remaining data will be analyzed to determine the effect of the different doses of semaglutide compared with the placebo.

Who can join the trial?

3 criteria

Be a man or a woman who is at least 18 years old when you sign the consent form.
Have a body mass index (BMI) of 30 kg/m² or higher. BMI is a simple number that compares your weight to your height.
If your BMI is between 27 kg/m² and less than 30 kg/m², you must also have at least one of these weight‑related health problems: high blood pressure (also called hypertension), abnormal blood fats (called dyslipidemia), breathing interruptions while sleeping (called obstructive sleep apnea), or any heart or blood‑vessel disease (called cardiovascular disease).

Who cannot join the trial?

8 criteria

Having a history of type 1 diabetes (T1D) or type 2 diabetes (T2D).
Having an HbA1c level of 6.5% or higher (HbA1c is a blood test that shows average blood sugar over the past few months) at the screening visit.
Having a current eating disorder such as anorexia, bulimia, or binge‑eating disorder.
Gaining or losing more than 5 kg (about 11 lb) in the 90 days before screening, even if your medical records do not show it.
Having a history of chronic pancreatitis (long‑term inflammation of the pancreas).
Having you or a first‑degree relative (parent, sibling, or child) with a history of multiple endocrine neoplasia type 2 (a rare inherited condition that can cause certain tumors), pancreatic cancer, or medullary thyroid carcinoma (a type of thyroid cancer).
Using any blood‑sugar‑lowering medicines (including metformin) within 90 days before screening.
Using a GLP‑1RA (a medication that mimics a hormone to help control blood sugar and appetite) within 90 days before screening.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
PAREXEL International GmbH
Berlin, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

CAM2056 (semaglutide) is an investigational medicine that is given as a liquid injection under the skin. It contains semaglutide, a substance that works like a natural hormone in the body to help control appetite and food intake. In the trial, participants received this medication to see if it could lead to a noticeable loss of body weight compared with no active treatment. The injection is designed to stay in the body for an extended period, allowing less frequent dosing while maintaining its effect on reducing hunger and supporting weight loss.

Semaglutide

What is already known about the treatment

CAM2056 10 mg/mL (semaglutide subcutaneous depot)
This medication is a clear liquid that is injected just under the skin with a small needle. Semaglutide is already approved and well documented in medical research for treating type 2 diabetes and helping people lose weight. It works by copying a natural hormone that tells the pancreas to release insulin and also signals the brain to feel full, which lowers blood sugar and reduces appetite. It belongs to the drug class called GLP‑1 receptor agonists, a type of incretin mimetic.
CAM2056 20 mg/mL (semaglutide subcutaneous depot)
This medication is also a clear liquid given by a sub‑cutaneous injection using a small needle. Semaglutide is an approved and extensively studied drug for type 2 diabetes and obesity, and it continues to be evaluated in many clinical studies. It mimics a natural hormone that activates the GLP‑1 receptor, helping the body release insulin and making the person feel less hungry, which supports weight loss. It is classified as a GLP‑1 receptor agonist, which is a kind of incretin‑based therapy.

Investigated diseases

Body weight management - Body weight management refers to the ongoing process of maintaining a healthy body weight through regulation of energy intake and expenditure. It typically involves individuals who have excess body weight that can slowly increase over time if calorie balance is positive. Without effective management, weight may continue to rise, leading to higher body mass. The condition can remain stable, improve, or worsen depending on lifestyle factors. It is monitored by measuring changes in body weight over weeks or months.