What Profil does

Profil Institut für Stoffwechselforschung GmbH is a privately held full-service Contract Research Organization (CRO) headquartered in Neuss, Germany, specializing in early-phase clinical development for diabetes and obesity therapeutics. Founded in 1999 as a spin-off from the Department of Metabolic Diseases and Nutrition at the University of Düsseldorf, the company serves pharmaceutical and biotech sponsors and medical device manufacturers globally. Profil's named enterprise customers include virtually every major anti-diabetic franchise — Novo Nordisk, Eli Lilly, Sanofi, Boehringer Ingelheim, AstraZeneca, Hoffmann-La Roche, Pfizer, Novartis, GlaxoSmithKline, and Johnson & Johnson — alongside medtech firms such as Medtronic, BD, and MannKind.

The company's core platform centers on the hyperinsulinemic-euglycemic glucose clamp, the gold standard for assessing insulin sensitivity, often combined with stable isotope dilution techniques and adipose/muscle tissue biopsies to produce detailed pharmacodynamic and pharmacokinetic characterization. Profil operates proprietary technology including the ClampArt automated glucose clamp device, in-house manufactured DLC systems and rinse adapters built under the EU Medical Device Regulation, and a GMP-certified pharmacy for investigational medicinal product handling. The service portfolio spans clinical development (pharmacodynamics, pharmacokinetics, bioequivalence/biosimilar, bridging, safety/tolerability), an extensive methods catalog (glucose clamp, stable isotopes, BodPod, biopsy, pancreatic clamp, transient elastography, flow-mediated dilation, retinal laser, skin laser Doppler, standardized nutrition, and exercise/energy expenditure), and support services covering patient recruitment, data management, statistical analysis, medical writing, and regulatory handling.

Revenue is generated on a professional-services basis through Phase I-II clinical trial contracts, marketed through a content-driven GTM motion (online seminars since May 2015, scientific blog, monthly newsletter, conference posters) combined with enterprise field sales and free clinical trial consultations. The firm holds ISO 9001:2015, ISO 13485:2016, and ISO 27001 certifications, is a member of BVMA, and reports 360+ peer-reviewed publications with cumulative impact factor above 1,000, 500+ conference abstracts, and 380+ oral presentations. Profil reports 251-500 employees and operates a website at https://www.profil.com.

Name

Profil

Legal name

Profil Institut für Stoffwechselforschung GmbH

Website

https://profil.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

251–500 employees

Short description

Profil Institut für Stoffwechselforschung GmbH is a privately held German full-service CRO specializing in early-phase clinical trials for diabetes and obesity therapeutics. It serves major pharmaceutical, biotech, and medical device sponsors worldwide using proprietary glucose clamp and isotope dilution methodologies.

Ownership category

akta.pro rank

Headquarters

HQ city

Neuss

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Others

Revenue model

1. Clinical Trial Services: Profil generates revenue as a full-service CRO providing clinical development services to pharmaceutical and biotech companies. Services include pharmacodynamics, pharmacokinetics, biosimilar studies, safety and tolerability studies, bridging studies, and regulatory consulting for early-phase clinical trials in diabetes and obesity.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels8 records

Core offering

Profil operates as a full-service contract research organization (CRO) providing early-phase (Phase I-II) clinical trial services exclusively focused on diabetes and obesity drug and medical device development. Core services include pharmacodynamic and pharmacokinetic studies, bioequivalence/biosimilar assessments, safety and tolerability trials, and bridging studies. The offering is anchored by the gold-standard hyperinsulinemic-euglycemic glucose clamp technique, often combined with isotope dilution, adipose/muscle biopsies, body composition analysis, and other specialized metabolic measurement methods. Supporting services include a GMP certified pharmacy, patient recruitment, regulatory handling, data management, statistics, and medical writing.

Product overview

Profil is a full-service CRO (Contract Research Organization) for early clinical development in diabetes and obesity, offering a unified platform of clinical trial services. The core portfolio centers on Phase I-II clinical trials with specialized assessment methods including the glucose clamp technique (often combined with isotope dilution and tissue biopsies), pharmacodynamics, pharmacokinetics, bioequivalence/biosimilar studies, safety/tolerability assessments, and bridging studies. The company provides comprehensive support services including patient recruitment, a GMP-certified pharmacy, data management, statistics, medical writing, and regulatory handling. Research expertise spans diabetes treatments (insulin analogs, glucose-lowering medications, incretins), medical technology (insulin pumps, artificial pancreas, CGM), and obesity treatments (MASLD/MASH, cardiometabolic research). The company also offers knowledge dissemination through online seminars and scientific publications.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Development Services Comprehensive early-phase (Phase I-II) clinical trial services including pharmacodynamics, pharmacokinetics, bioequivalence/biosimilar studies, safety and tolerability assessments, and bridging studies for diabetes and obesity treatments.
• Glucose Clamp Studies Gold-standard hyperinsulinemic-euglycemic glucose clamp technique for assessing insulin sensitivity and pharmacodynamic effects of compounds in early-phase clinical trials.
• Stable Isotope / Metabolic Flux Studies Stable isotope techniques combined with clamp procedures for measuring metabolic fluxes and glucose production rates in clinical studies.
• Adipose Tissue and Muscle Biopsy Tissue biopsy services for analyzing adipose and muscle tissue composition, often combined with glucose clamp studies for pharmacodynamic characterization.
• Bodpod / Body Composition Analysis Air displacement plethysmography for measuring body composition in obesity and diabetes clinical trials.
• GMP Certified Pharmacy Services In-house GMP-certified pharmacy for handling investigational medicinal products in clinical trials.
• Patient Recruitment Specialized patient recruitment services for diabetes and obesity clinical trials.
• Data Management, Statistics and Medical Writing Comprehensive data management, statistical analysis, and medical writing services for clinical trial documentation.
• Regulatory Handling Regulatory affairs support for clinical development including submissions and compliance management.
• Artificial Pancreas / Closed-Loop Systems Clinical Trials Clinical trials for artificial pancreas and hybrid closed-loop insulin delivery systems, including participation in the AP@home project for closed-loop insulin delivery in type 1 diabetes.
• Insulin Pump Therapy Clinical Trials Clinical research services for insulin pump systems and automated insulin delivery technologies.
• Continuous Glucose Monitoring (CGM) Clinical Trials Clinical trials evaluating continuous glucose monitoring devices and their integration with insulin delivery systems.

Quantifiable outcome

• 360+ peer-reviewed publications with cumulated impact factor > 1,000
• +2 more outcomes

Named customers19 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Antaros MedicalminorStrategic or Co-development Partner · 9 April 2026Featured speaker collaboration for Xtalks webinar on 'Underneath the Lost Kilos: Muscle Composition, Preservation and Function' focused on assessing muscle composition changes during weight loss in clinical trials.
• Steno Diabetes Centre AarhusminorStrategic or Co-development Partner · 9 April 2026Featured speaker collaboration for Xtalks webinar on muscle composition changes during weight loss in clinical trials, bringing together expertise from Profil, Antaros Medical, and Steno Diabetes Centre Aarhus.
• Invictus TherapeuticsminorImplementation/ SI/ Consulting Partner · 12 January 2026Profil serving as the clinical trial site for Invictus Therapeutics' first-in-human Phase 1 trial of a next-generation ultra-rapid insulin analog for automated insulin delivery systems, funded by Breakthrough T1D Industry Discovery and Development Partnership award.
• AP@home ConsortiumcoreStrategic or Co-development PartnerProfil has been involved in the development of an artificial pancreas as part of the AP@home project, collaborating with other research institutions and companies to advance closed-loop insulin delivery systems (artificial pancreas technology) for people with type 1 diabetes.
• PhysiogenexminorStrategic or Co-development PartnerJoint online seminar collaboration titled 'Of Mice and Men: Insulin sensitivity in preclinical and clinical trials' bringing together preclinical metabolic disease expertise from Physiogenex and clinical trial expertise from Profil Germany.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medpace: Medpace is a mid-sized, science-focused CRO with a strong metabolic/endocrine therapeutic area and full-service Phase I–III capabilities that overlap Profil's specialty diabetes/obesity work.
• Celerion: Celerion is an early-phase clinical research organization with established metabolic and endocrine expertise, including glucose clamp methodology, that directly competes with Profil for Phase I diabetes and obesity studies.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a specialty-focused mid-size CRO with metabolic and endocrinology expertise, serving pharma/biotech sponsors on trials that overlap Profil's diabetes/obesity portfolio.
• Quotient Sciences: Quotient Sciences provides early-phase clinical pharmacology and drug development services, including healthy-volunteer and metabolic studies, competing with Profil for early-phase diabetes/obesity trials.

Broad incumbents

• ICON plc: ICON is a global full-service CRO offering end-to-end Phase I–IV capabilities including metabolic disease, providing broader geographic reach and scale than Profil for sponsors wanting one-vendor programs.
• Fortrea: Fortrea (spun off from Labcorp Drug Development) is a large clinical development CRO with early-phase and specialty capabilities that compete with Profil for global metabolic-disease programs.
• Parexel International: Parexel is a large global CRO with established metabolic and early-phase development services that overlap Profil's therapeutic area while offering broader geographic and functional coverage.
• IQVIA: IQVIA is the world's largest CRO with broad early-phase and metabolic-disease capabilities, leveraging scale, data, and global site footprint that compete with Profil's specialist positioning.

Regional players

• CRS Clinical Research Services: CRS is a Germany-based early-phase clinical research organization with overlapping metabolic and Phase I capabilities, making it a like-for-like regional peer in Profil's home market.
• Nuvisan: Nuvisan is a Germany/Europe-headquartered CRO with early-phase clinical and bioanalytical capabilities serving pharma sponsors, providing regional competition to Profil in European metabolic studies.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Profil