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

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