Obesity or Overweight
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
Interventions
DRUGPetrelintide
Petrelintide will be administered subcutaneously to participants once weekly
COMBINATION_PRODUCTEnicepatide
Enicepatide will be administered subcutaneously to participants once weekly
DRUGPetrelintide-matching Placebo
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
COMBINATION_PRODUCTEnicepatide-matching Placebo
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
Sponsors
Hoffmann-La Roche
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to \< 30 kg/m² with at least one weight-related comorbidity * History of at least one self-reported unsuccessful dietary effort to lose body weight Key
Exclusion criteria
* HbA1c ≥ 48 mmol/mol (6.5%) at screening * History of Type 1 or Type 2 Diabetes * Self-reported change in body weight \> 5 kg within 90 days prior to screening * Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed \> 1 year prior to or during screening) * Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner) * Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening * Current or previous treatment with petrelintide or any other amylin analog * Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity * History of severe psychiatric disorders * History of any hematologic conditions that may interfere with HbA1c measurement * Known history or presence of pancreatitis * Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility * New York Heart Association Functional Classification IV heart failure * Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Body Weight between Arms 1 and 6 | From Baseline to Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body Weight (kilograms [kg]) | From Baseline to Week 40 |
| Change in Body Mass Index (kilograms per square meter [kg/m²]) | From Baseline to Week 40 |
| Change in Waist Circumference (centimeter [cm]) | From Baseline to Week 40 |
| Change in Hemoglobin A1c (HbA1c) (percentage-points) | From Baseline to Week 40 |
| Change in Fasting Insulin | From Baseline to Week 40 |
| Change in Fasting Glucose | From Baseline to Week 40 |
| Change in Systolic Blood Pressure | From Baseline to Week 40 |
| Change in Diastolic Blood Pressure | From Baseline to Week 40 |
| Change in High-Density Lipoprotein (HDL) Cholesterol | From Baseline to Week 40 |
| Change in Low-Density Lipoprotein (LDL) Cholesterol | From Baseline to Week 40 |
| Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol | From Baseline to Week 40 |
| Change in Non-HDL Cholesterol | From Baseline to Week 40 |
| Change in Total Cholesterol | From Baseline to Week 40 |
| Change in Free Fatty Acids | From Baseline to Week 40 |
| Change in Triglycerides | From Baseline to Week 40 |
| Change in High-Sensitivity C-reactive Protein (hsCRP) | From Baseline to Week 40 |
| Number of Participants with Adverse Events (AEs) | From Baseline to Week 40 |
| Percentage Change in Body Weight between Arms 2, 3 and Arm 6 | From Baseline to Week 40 |
| Percentage of Participants Achieving Body Weight Loss | From Baseline to Week 40 |
| Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5 | From Baseline to Week 40 |
Contacts
CONTACTReference Study ID Number: CC46372 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed