Semaglutide 2.4 mg in Patients With Poor Weight-loss

NCT05073835 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 142522
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded, randomised, placebo-controlled trial of semaglutide 3.0 mg/ml in patients with poor weight-loss following bariatric surgery. The primary aim of this trial is to determine whether, and the extent to which, 68 weeks of subcutaneous semaglutide 3.0 mg/ml causes greater percentage weight loss (%WL), reduction in adiposity, improvement in metabolic and inflammatory indices and health-related quality of life (HRQoL) than placebo, in patients with poor weight loss following gastric bypass or sleeve gastrectomy.

Conditions

Obesity; Diabetes; Metabolic Syndrome

Keywords

obesity; diabetes; semaglutide

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Percentage of total weight loss

  68 weeks

Secondary Outcomes (14)

• body weight reduction ≥10%

  68 weeks

• body weight reduction ≥15%

  68 weeks

• body weight reduction ≥20%

  68 weeks

• Change in circulating HbA1c levels

  68 weeks

• Change in circulating HbA1c levels in participants with pre-diabetes at baseline

  68 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Semaglutide 2.4mg/week subcutaneous injection for 68 weeks. The treatment includes an initial 16-week escalation phase followed by 52 weeks of treatment at study dose, i.e., 2.4mg/week.

Drug: Semaglutide 3 mg

Control

PLACEBO COMPARATOR

Placebo administration, once weekly, subcutaneous injection.

Drug: Placebo

Interventions

Semaglutide 3 mg DRUG

Semaglutide 2.4 mg/week, subcutaneous injection. Treatment dose: 16 weeks of dose escalation + 52 weeks of study dose (i.e., 2.4 mg/week).

Intervention

Placebo DRUG

Placebo

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, ≥1 year primary GB or primary SG, with poor weight-loss (\<20% WL) that is not caused by either a surgical or psychological problem.
• Adults, 18-65 years inclusive.
• Females of childbearing potential and female partners of male participants must be willing to use highly effective method of contraception (hormonal or barrier method of birth control; abstinence) (Appendix 2) from the time consent is signed until 2 months after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to randomisation. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• A self-reported ≤5 % variation in body weight over preceding 3 months.
• Fluent in English and able to understand and complete questionnaires.
• Participants capable to provide written informed consent and comply with the trial protocol.

You may not qualify if:

• Bariatric surgical procedure other than GB and SG, or revision bariatric surgery of any operation type.
• Personal history of type I diabetes or type II diabetes mellitus currently treated with insulin.
• Concomitant use of GLP-1R agonist or DPPIV-inhibitors.
• Female who is pregnant, breast-feeding, or intends to become pregnant.
• Current participation in other clinical intervention trial.
• History of suicidal attempt in the previous 5 years or untreated severe depression or mental health condition assessed by direct questioning.
• Symptomatic gallstone disease
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
• Renal impairment measured as glomerular infiltration rate (eGFR \<15 ml/min 1.73 m2
• Known or suspected hypersensitivity to semaglutide or any of the excipients involved in their formulation.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
• Personal history of acute pancreatitis 180 days before screening or chronic pancreatitis.
• Uncontrolled thyroid disease.
• History of stroke, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Janine Makaronids

London, WC1E 6JF, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Metabolic Syndrome

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded: both participants and study doctors will be blind to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 3b, double-blinded, randomised, parallel group trial

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 12, 2021
• Study Start: November 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GB (1)