Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

Study Overview
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Brief Summary
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A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: AC2307
* Drug: placebo
* Drug: AC2307
* Drug: placebo
* Drug: AC2307
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Is obese with a body mass index (BMI) ≥30 kg/m^2 to ≤45 kg/m^2, or is overweight with a BMI ≥27 kg/m^2 to <30 kg/m^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis) Exclusion Criteria: Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start Has donated blood within 2 months before study start or is planning to donate blood during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AC2307<br>* subcutaneous, twice daily, low dose<br>|
| Experimental: 2<br> | Drug: AC2307<br>* subcutaneous, twice daily, middle dose<br>|
| Experimental: 3<br> | Drug: AC2307<br>* subcutaneous, twice daily, high dose<br>|
| Placebo Comparator: 4<br> | Drug: placebo<br>* subcutaneous, twice daily, low dose<br>|
| Placebo Comparator: 5<br> | Drug: placebo<br>* subcutaneous, twice daily, middle dose<br>|
| Placebo Comparator: 6<br> | Drug: placebo<br>* subcutaneous, twice daily, high dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects |  | 24 weeks | 
| To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes |  | 24 weeks | 
| To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, weight loss, Amylin, AC2307