Phase 4 N=24 Randomized Triple-blind Treatment

Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT01834404 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Gastric Emptying of Solids Half-Time (T 1/2) — 109; 88 minutes — p=0.057

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Phentermine-Topiramate ER (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Gastric Emptying of Solids Half-Time (T 1/2)	109; 88	0.057
PRIMARY Fasting Gastric Volume	227; 261	0.36
PRIMARY Postprandial Gastric Volume	680; 681	0.99
PRIMARY Volume to Fullness	570; 630	0.45
PRIMARY Maximum Tolerated Volume	966; 1108	0.22
PRIMARY Buffet Meal Intake	728; 988	0.032 sig
SECONDARY Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours	0.56; 0.66	0.052
SECONDARY Solid Gastric Emptying: Proportion Remaining at 4 Hours	0.09; 0.16	0.030 sig
SECONDARY Change in Postprandial Gastric Volume	453; 420	0.35
SECONDARY Fasting Ghrelin	78.1; 82.6	0.72
SECONDARY Peak Postprandial Level of Cholecystokinin (CCK)	8.1; 8.3	0.90
SECONDARY Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)	13.0; 11.9	0.54
SECONDARY Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)	195.3; 166	0.26

Summary

Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric emptying, gastric accommodation, satiety, and satiation in obese participants.

Eligibility Criteria

INCLUSION CRITERIA

Obese subjects with BMI> 30 Kg/m^2. Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
Women of childbearing potential will have negative pregnancy test before initiation of medication.

EXCLUSION CRITERIA

Weight >300 lbs, which is the limit of safety for the SPECT scanner
Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)
Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)
Concentration of fasting glucose greater than 240 mg/dl
Concentration of triglycerides greater than 400 mg/dl
Type 1 Diabetes
Use of anti-diabetic drugs other than metformin,
History of nephrolithiasis,
Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire-9, 21 total score ≥10).
Concomitant use of Monoamine Oxidase Inhibitors (MAOI) (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants
Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale [HADS] self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety and Depression Scale (HADS) score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
End stage renal disease or liver cirrhosis
Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.

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Data sourced from ClinicalTrials.gov (NCT01834404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.