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A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM

Alnylam Pharmaceuticals logo

Alnylam Pharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Type 2 Diabetes Mellitus (T2DM)

Treatments

Drug: ALN-KHK
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05761301
ALN-KHK-001

Details and patient eligibility

About

To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
  • Part A: body mass index (BMI) ≥27 kg/m^2 and ≤34.9 kg/m^2
  • Part B: BMI ≥30 kg/m^2 to ≤39.9 kg/m^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%
  • Part B: Confirmed T2DM diagnosis

Exclusion criteria

  • Parts A and B: has received an investigational agent within the last 30 days
  • Part A: History of Type 1 or Type 2 diabetes
  • Part B: History of Type 1 diabetes

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

160 participants in 4 patient groups, including a placebo group

Part A: ALN-KHK
Experimental group
Description:
Participants will be administered a single dose of ALN-KHK.
Treatment:
Drug: ALN-KHK
Part A: Placebo
Placebo Comparator group
Description:
Participants will be administered a single dose of placebo.
Treatment:
Drug: Placebo
Part B: ALN-KHK
Experimental group
Description:
Participants will be administered a multiple doses of ALN-KHK.
Treatment:
Drug: ALN-KHK
Part B: Placebo
Placebo Comparator group
Description:
Participants will be administered a multiple doses of placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

16

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Central trial contact

Alnylam Clinical Trial Information Line; Alnylam Clinical Trial Information Line

Data sourced from clinicaltrials.gov

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