NCT01535014 is a Phase 3 clinical trial of Dietressa in Obesity, sponsored by Materia Medica Holding.

Who is sponsoring NCT01535014?

NCT01535014 is sponsored by Materia Medica Holding.

What drugs are being tested in NCT01535014?

Interventions in NCT01535014: Dietressa, Placebo.

Is NCT01535014 still recruiting?

NCT01535014 is currently completed. Last updated 1 November 2018.

Are results published for NCT01535014?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-01 · How we verify

NCT01535014

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

Completed Phase 3 Results posted Last updated 1 November 2018

What this trial tests

Phase 3 trial testing Dietressa in Obesity in 493 participants. Completed in 1 June 2013.

Timeline

12 December 2011

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Materia Medica Holding
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	493
Start date	12 December 2011
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	17 locations across Russia

Drugs / interventions tested

Dietressa — full drug profile →
Placebo

Conditions studied

Obesity — all drugs for Obesity →

Sponsor

Materia Medica Holding — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Body Weight Change After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Relative Change in Body Weight After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment

Sponsor's own description

The purpose of this study is: * To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. * To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Obesity

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting

Other Materia Medica Holding trials

Trials by the same sponsor.

NCT07171099 — Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children · Phase 3 · recruiting
NCT06901297 — The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients · Phase 3 · recruiting
NCT06715891 — Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years · Phase 3 · recruiting
NCT06263881 — Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia · Phase 3 · completed
NCT06284265 — Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01535014 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Materia Medica Holding
Last refreshed: 1 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01535014.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing